Ongoing Trials
Are you a healthy male aged 18-40?
- Who we are
Our 2 research units, based in London at St George’s University Hospital and Mayday University Hospital, provide you with the safest and most comfortable facilities.
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What is this all about?
- Aim of the Study
GTx-758 is an investigational medicinal product being developed for the treatment of prostate cancer, with the anticipation that it will have fewer side effects than other treatments currently available on the market. GTx-758 is not available by prescription or as an over-the-counter medication but is currently under research in clinical trials.
GTx-758 works by reducing the testosterone levels in the body, in a similar way to current available treatments, however the study drug (GTx-758) is thought to be more effective and therefore cause fewer side effects.
We are looking for healthy non-smoking male volunteers aged 18 to 40, inclusive.
- Who is suitable for this study?
To qualify for participation you need to:
- Be a healthy male aged 18 to 40, inclusive.
- Be a non-smoker, i.e. you have not smoked in the past 6 months.
- Have a Body Mass Index (BMI) is between 18-30 kg/m2, inclusive (your BMI is calculated using the formula: weight (in kilograms) divided by height (in metres) squared).
- Be able to provide written consent, communicate and are able to understand and be willing to comply with study procedures, restrictions and requirements.
- Be in good health as determined from safety blood and urine tests, physical examination, ECG and 24-hour heart monitoring.
- Agree to use acceptable methods of contraception from the day you are given the study drug until 3 months after you have completed the study.
By acceptable methods of contraception we mean:
- If your female partner is pregnant or lactating, you should use a condom with spermicidal foam/gel/film/cream/suppository, even if you have undergone documented surgical sterilisation.
- If your female partner could become pregnant, you should use a condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, even if you have undergone documented surgical sterilisation.
- If your female partner uses oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or subdermal implants, you should also use a condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- If your female partner has undergone a documented tubal ligation (female sterilisation), you should also use a condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- If your female partner has undergone a documented placement of an intrauterine device (IUD) or intrauterine system (IUS) you should also use a condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
Other restrictions and exclusions apply – please ask for details.
- What will happen?
If you successfully pass the telephone screening you will be invited to our facility where you will undergo a screening examination. This is vital to ensure it is safe for you to take part in the trial. You will be required to attend a screening visit within 21 days before the start of the study. If you pass the screening visit you will be invited to take part in the study.
This study is divided up into three parts; Part A, Part B and Part C (you will only be included in one part of the study).
Participation for Part A requires you to stay at our clinical unit at Mayday University Hospital for one residential stay of 8 days and 7 nights. In addition, you will be required to attend the unit for an external visit on day 14.
Participation for Part B is on an out-patient basis only with the exception of an overnight stay in our clinical unit on day -1 in preparation for the first dosing on day 1. In addition, you will need to attend the unit on days 3, 7, 10, 14, 17, 21, 24, 28, 35, and 42 for outpatient visits. Participation for Part B will last approximately 2 months.
Participation for Part C requires you to stay at our clinical unit for one residential stay of 17 days and 16 nights. In addition, you will need to attend the unit on days 17, 21, 24, 28, 35 and 42 for outpatient visits. Participation for Part C will last approximately 2 months.
- Study Dates
We have been asked to undertake this study in the following groups:
Part A; 10 healthy males aged 18-40 assigned to one treatment group, study dates are listed as follows:
Group 1
Admissions: 25 March 2010
Dismissal: 2 April 2010
Follow-up visit: 8 April 2010
Part B; 20 healthy male volunteers aged 18-40 assigned to one of two possible treatment groups; study dates for each group are listed as follows:
Group 2
Admissions: 27 February 2010
Dismissal: 28 February 2010
Out-patient visits:
2 March 2010
6 March 2010
9 March 2010
13 March 2010
16 March 2010
20 March 2010
23 March 2010
27 March 2010
30 March 2010
3 April 2010
6 April 2010
10 April 2010
13 April 2010
17 April 2010
20 April 2010
24 April 2010
Group 3
Admissions: 11 March 2010
Dismissal: 12 March 2010
Out-patient visits
14 March 2010
18 March 2010
21 March 2010
25 March 2010
28 March 2010
1 April 2010
4 April 2010
8 April 2010
11 April 2010
15 April 2010
18 April 2010
22 April 2010
25 April 2010
29 April 2010
2 May 2010
6 May 2010
Part C; 20 healthy male volunteers aged 18-40 assigned to one treatment group, study dates are listed as follows:
Group 4
Admissions: 14 April 2010
Dismissal: 30 April 2010
Out-patient visits:
1 May 2010
5 May 2010
8 May 2010
12 May 2010
15 May 2010
19 May 2010
22 May 2010
26 May 2010
29 May 2010
2 June 2010
5 June 2010
9 June 2010
- What's in it for you?
For Part A; you will receive £740 for your time on completion of the study, once follow-up results are confirmed, checked and deemed satisfactory by the study doctor. You will be paid an additional bonus of £360 subject to your satisfactory compliance with the documents provided before study commencement (Volunteer Information sheet and Informed Consent, the Richmond Pharmacology Volunteer Charter and all other unit regulations).
The total amount that you could be paid for Part A participation is £1100. This payment includes all travel expenses.
For Part B; you will receive £780 for your time on completion of the study, once follow-up results are confirmed, checked and deemed satisfactory by the study doctor. You will be paid an additional bonus of £380 subject to your satisfactory compliance with the documents provided before study commencement.
The total amount that you could be paid for Part B participation is £1,160. This payment includes all travel expenses.
For Part C; you will receive £1,780 for your time on completion of the study, once follow-up results are confirmed, checked and deemed satisfactory by the study doctor. You will be paid an additional bonus of £880 subject to your satisfactory compliance with the documents provided before study commencement.
The total amount that you could be paid for Part C participation is £2,660. This payment includes all travel expenses.
- Want to find out more?
If you are interested in finding out more visit
http://www.trials4us.co.uk to register
Or
Call us free on 0800 085
64 64 and speak to a member of our Volunteer Recruitment Team.
A
detailed information sheet is available on request.
9069_version 2_21 12 09.doc
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Are you a healthy male or female aged 18-85?
- What is this all about?
The main aim of the study is to assess how effective the study medication (HT61) is in the treatment of MRSA.
MRSA (also known as Methicillin Resistant Staphylococcus aureus) is now present in most hospitals in the UK and most people carry the bacterium in and on their body, skin and mainly in their nose. Carriage of MRSA does not harm most people, but the bacterium can be passed on to other people. If the carrier has surgery, it can enter the wound and cause a clinical infection, which is difficult to treat, because the organism is often resistant to a wide range of antibiotics. Therefore, there is a need for a new topical (applied to the outside of the body) antibiotic to clear the nose of MRSA.
HT61 is a novel topical antibiotic gel, to be used on the outside of the body, which is active against a certain type of bacteria known as Methicillin Resistant Staphylococcus aureus (MRSA) and against other types of skin bacteria. “Novel” means it is not available by prescription or as an over-the counter medication but is currently under research in other clinical trials.
The main aim of this study is to assess how effective HT61 (the study medication) is at 2 dose frequencies and to see how effective HT61 is compared to mupirocin (‘the control’), a medication which is already on the market to treat MRSA.
We are looking for healthy male and female volunteers, aged 18 to 85 (inclusive).
- Who is suitable for this study?
To qualify for participation you need to:
- Be a healthy male or female aged 18 to 85 (inclusive).
- Be able to provide written consent, communicate and are able to understand and be willing to comply with study procedures, restrictions and requirements
- Be in good health as determined by your medical history, routine blood samples, vital signs and ECGs (electrical readings of the heart).
- Be able to attend all visits and complete the study.
- Male or female subjects who are using a medically acceptable method of contraception or of non-childbearing potential (i.e. surgically sterile-bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing or naturally postmenopausal for at least one year with a Screening FSH level ≥ 40 mIU/L). A negative serum pregnancy test is required at Screening for females.
By medically acceptable methods of contraception we mean:
Female subjects
Female subjects of childbearing potential must use medically acceptable methods of contraception from the time of the first administration of the study medication until 3 months following administration of the last application of study medication. Acceptable methods include:
- Oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or sub-dermal implants and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository};
- A documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and the use of a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository};
- Medically prescribed topically-applied transdermal contraceptive patch and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository};
- Documented tubal ligation (female sterilisation). In addition, a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository} should also be used;
- Double barrier method: Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
- Abstinence.
Male subjects
Male subjects must use medically acceptable methods of contraception if their female partners are pregnant from the time of the first administration of the study medication until 3 months following administration of the last application of study medication. Acceptable methods include:
- Condom
- If the subject has undergone surgical sterilisation (vasectomy with documentation of azoospermia) a condom with spermicidal foam/gel/film/cream/suppository should also be used.
- Male subjects must use acceptable methods of contraception if the male subject’s partner could become pregnant from the time of the first administration of study medication until 3 months following administration of the last application of study medication. The acceptable methods of contraception are as follows:
- Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
- Surgical sterilisation (vasectomy with documentation of azoospermia) and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository};
- The female partner uses oral contraceptives (combination estrogen/progesterone pills), in-jectable progesterone or subdermal implants and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository};
- Medically prescribed topically-applied transdermal contraceptive patch and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository};
- The female partner has undergone documented tubal ligation (female sterilisation). In addition, a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository} should also be used;
- The female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and the use of a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository};
- Abstinence.
Other restrictions and exclusions apply – please ask for details.
- What will happen?
If you are interested in taking part you will need to contact us to register your interest.
If you successfully pass the telephone screening you will be invited to our facility where you will undergo a pre-screening examination up to 42 days before the first dose of the study drug, as well as a screening visit within 32 days before the start of the study. You will also need to perform some nasal swabs at home in the 2 weeks before the start of the study. These are vital to ensure it is safe for you to take part in the trial. If you pass the screening visit you will be invited to take part in the study.
Participation for this study is on an out-patient basis only. You will be required to stay in the unit until 8 hours after you have received the first application of the study medication. Out-patient visits will be scheduled for 48 hours, 7 days and 30 days after your final application of study medication (on days 8, 12 and 35 after the last application of study medication).
In addition, you will be required to perform swabs at home monthly until 6 months after dosing, and you will need to be contacted by telephone in order to perform a final follow up assessment that will take place between 90 days and 6 months following the last application of study treatment.
- Study Dates
Study dates for each group visit are listed as follows;
Group 1
Admissions: 11 March 2010
Outpatient visits
17 March 2010
22 March 2010
14 April 2010
Group 2
Admissions: 12 March 2010
Outpatient visits
18 March 2010
23 March 2010
15 April 2010
Group 3
Admissions: 18 March 2010
Outpatient visits
24 March 2010
29 March 2010
21 April 2010
Group 4
Admissions: 19 March 2010
Outpatient visits
25 March 2010
30 March 2010
22 April 2010- What’s in it for you?
You will receive at least £420 for full participation in this trial, excluding an additional compliance bonus of up to £210.
The total amount that you could be paid for study participation is £630 (this payment includes all travel expenses).
- Want to find out more?
Or
Call us free on 0800 085 64 64 and speak to a member of our Volunteer Recruitment Team.
A detailed information sheet is available on request.
Ref: 9054_version 3_20 11 09.doc
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Are you a healthy male or female aged 18-55?
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What is this all about?
We have been asked to undertake a study on healthy volunteers aged 18 - 55. The main aim of the study is to assess how well the body tolerates the study drug (BT063) and to see if there are any side effects. We will also monitor the effects of the drug on the immune system. The study drug has never been given to humans before and as such this is a first into man trial.
The study drug (BT063) has been developed to aid in the treatment of patients with a condition known as systemic lupus erythematosus (SLE). This is a type of autoimmune disease.
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Aim of the Study
The main aim of this study is to see what effect the study drug, BT063 has on the body. We are looking for healthy volunteers, males and females aged 18-55. BT063 is designed to block a part of the immune system that is involved in autoimmune disease.
The immune system exists to protect the body from illnesses caused by many things, including viruses, bacteria and cancer. One way it does this is via the production of antibodies. These are proteins that are generated by the immune system, which circulate in the blood and attach to foreign proteins called antigens in order to destroy or neutralize them. For example, when you are exposed to a virus, your body will produce antibodies to help rid your system of the infection.
However, sometimes the immune system confuses its own body as foreign and attacks itself (autoimmune disease). These conditions lead to the production of molecules known as auto-antibodies, which actually cause damage to the patient’s own body. In SLE, the damage can involve a large number of organs. It is estimated that around 30,000 people have the condition in the UK. Currently there is no cure for this condition.
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Who is suitable for this study?
To qualify for participation you need to:
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Be able to provide written informed consent prior to any study specific procedures.
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Be a healthy male or female aged 18 to 55 years.
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Have a body weight of no less than 50kg nor more than 110 kg and have a BMI within 18-30 kg/m2 inclusive.
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Able to communicate effectively with the study personnel and are able to understand and be willing to comply with study procedures, restrictions and requirements.
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Be healthy as determined from safety blood and urine tests, physical examination, ECG and 24 hour heart monitoring.
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Have normal IL-10 levels as determined by a blood test.
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Agree to use acceptable methods of contraception from the day you are given the study drug until 4 months after you have completed the study. By acceptable methods of contraception we mean:
If you are female:
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and you could become pregnant, your partner should use a condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, or surgical sterilisation.
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and you use oral contraceptives (which are a combination oestrogen/progesterone pills), injectable progesterone or subdermal implants your partner should also use a barrier method such as condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository.
-
and you have undergone sterilisation, your partner should also use a barrier method such as a condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
-
and you have undergone a documented placement of an intrauterine device (IUD) or intrauterine system (IUS) your partner should also use a barrier method such as a condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
If you are male:
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and your female partner(s) is pregnant or lactating, you should use a condom with spermicidal foam/gel/film/cream/suppository, even if you have undergone surgical sterilisation.
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and your female partner(s) could become pregnant, you should use a condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, or surgical sterilisation.
-
and your female partner(s) uses oral contraceptives (which are a combination oestrogen/progesterone pills), injectable progesterone or subdermal implants you should also use a barrier method such as condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository.
-
and your female partner(s) has undergone sterilisation, you should also use a barrier method such as a condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
-
and your female partner(s) has undergone a documented placement of an intrauterine device (IUD) or intrauterine system (IUS) you should also use a barrier method such as a condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
Other restrictions and exclusions apply – please ask for details
-
What will happen?
This study is being conducted at our research facility at Mayday Hospital in London.
If you are interested in taking part you will need to contact us to register your interest.
If you successfully pass the telephone screening you will be invited to our facility where you will undergo a screening examination. This is vital to ensure it is safe for you to take part in the trial.
If you pass the screening visit you will be invited to take part in the study.
Participation requires you to stay at our clinical unit at Mayday University Hospital for one in-house period of 7 days and 6 nights. We will ask you to come in one day prior to the administration of the trial medication.
You will also be required to attend the unit for a series of external visits every seven days for approximately 12 weeks, depending on which treatment group you are assigned to. You will also be required to attend the unit or to be contacted by telephone or in writing to perform a final follow up assessment 2 years after the dose of study medication.
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Study Dates
We have been asked to undertake this study in the following groups;
24 Healthy males and females aged 18-55, assigned to one of 8 possible treatment groups.
Each treatment group will consist of 3 subjects.
Study dates for each group visit are listed as follows:
Group 1.i
Admissions: 4 March 2010
Dismissal: 10 March 2010
Follow up visits
12 March 2010
19 March 2010
26 March 2010
2 April 2010
9 April 2010
16 April 2010
23 April 2010
30 April 2010
7 May 2010
14 May 2010
21 May 2010
28 May 2010
Group 1.ii
Admissions: 14 March 2010
Dismissal: 20 March 2010
22 March 2010
29 March 2010
5 April 2010
12 April 2010
19 April 2010
26 April 2010
3 May 2010
10 May 2010
17 May 2010
24 May 2010
31 May 2010
7 June 2010
Group 2.i
Admissions: 24 March 2010
Dismissal: 30 March 2010
1 April 2010
8 April 2010
15 April 2010
22 April 2010
29 April 2010
6 May 2010
13 May 2010
20 May 2010
27 May 2010
3 June2010
10 June2010
17 June 2010
Group 2.ii
Admissions: 5 April 2010
Dismissal: 11 April 2010
Follow up visits
13 April 2010
20 April 2010
27 April
2010
4 May 2010
11 May 2010
18 May 2010
25 May 2010
1 June2010
8 June2010
15 June2010
22 June2010
29 June2010
- What's in it for you?
In recognition of the time and effort involved in taking part in this study, you will be paid £2050 on completion of the trial, once follow-up results are confirmed, checked and deemed satisfactory by the Research Doctor. This payment includes all travel expenses.
You will be paid a bonus of £400 subject to your satisfactory compliance with the documents provided before study commencement (Volunteer Information sheet and Informed Consent), the Richmond Pharmacology Volunteer Charter (unit regulations) and all unit rules.
The total amount that you could be paid is £2450.
- Want to find out more?
If you are interested in finding out more visit http://www.trials4us.co.uk to register
Or
Call us free on 0800 085 64 64 and speak to a member of our Volunteer Recruitment Team.
A detailed information sheet is available on request.
9008_version 3_06 10 09
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Are you a healthy male aged 18-45?
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What is this all about?
We have been asked to undertake a study on healthy male volunteers aged 18 - 45. The main aim of the study is to assess how well the body tolerates the study drug (ACT-280778) at different dosing levels and to evaluate the effect the body has on the study drug. We will also investigate the possible food interaction following a single oral dose of the study drug.
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Aim of the Study
The main aim is to see what effect the body has on the study drug, ACT-280778 and to evaluate the safety and tolerability of the study drug in healthy male volunteers. ACT-280778 is a new investigational medicinal product being developed for the treatment of Cardiovascular Disease.
Heart and circulatory disease is the most common cause of death in the UK and includes coronary heart disease, angina, heart attack, and stroke. In treatment of cardiovascular disease, particularly hypertension and angina, a group of drugs called ‘calcium channel blockers’ is one method of treatment currently being used. These drugs affect the way calcium is used in the blood vessels and heart muscle. This has a relaxing effect on the blood vessels. ACT-280778 works in similar way by blocking calcium channels.
ACT-280778 is not available on prescription or as an over-the-counter medication but is currently under research in other clinical trials.
We are looking for healthy non-smoking male volunteers, aged 18-45 (inclusive).
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Who is suitable for this study?
To qualify for participation you need to:
- Be a healthy male aged between 18 and 45 years, inclusive.
- You are willing to agree and sign the study informed consent prior to any study procedure taking place.
- You have a body mass index (BMI) between 20 and 30 kg/m2 (inclusive) at screening and your body weight is at least 50 kg. (Your BMI is calculated using the formula: weight (in kilograms) divided by height (in metres) squared).
- You are in good health as determined by your physical examination, safety blood and urine tests, electrocardiogram (ECG), and blood pressure measurements.
Other restrictions and exclusions apply – please ask for details.
-
What will happen?
This study is being conducted at our research facility at Mayday Hospital in London.
If you are interested in taking part you will need to contact us to register your interest.
If you successfully pass the telephone screening you will be invited to our facility where you will undergo a screening examination. This is vital to ensure it is safe for you to take part in the trial.
You will be required to attend a screening visit within 28 days before the start of the study. If you pass the screening visit you will be invited to take part in the study.
Participation requires you to stay at our clinical unit at Mayday University Hospital for one residential stay of 6 days and 5 nights. Volunteers who are assigned to the food effect group will need to attend two residential stays of 6 days and 5 nights, with a period of 7 to 10 days between each stay. In addition, you will be required to be contacted by telephone in order to perform a final follow up assessment 30 to 35 days after the last dose of study medication.
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Study Dates
We have been asked to undertake this study in the following groups;
64 Healthy males aged 18-45 (inclusive), assigned to one of 8 possible treatment groups.
Each group will have 8 subjects in it; study dates for each group visit are listed as follows:
Group 1.ii - 26 January 2010
Group 2.i - 7 February 2010
Group 2.ii - 9 February 2010
Group 3.i – 21 February 2010
Group 3.ii - 23 February 2010
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What’s in it for you?
Apart from doing something good, we will also compensate you for your time in the form of a monetary payment.
Single Dose Group
If you are allocated to the one of single dose groups, in recognition of the time and effort involved in taking part in this study, you will be paid £425 on completion of the trial, once follow-up results are confirmed, checked and deemed satisfactory by the Research Doctor.
This payment includes all travel expenses.
You will be paid a bonus of £215 subject to your satisfactory compliance with the Volunteer Information sheet and Informed Consent, the Richmond Pharmacology Ltd Volunteer Charter (unit regulations) and all unit rules.
The total amount that you could be paid is £640.
Food Effect Group
This payment includes all travel expenses.
You will be paid a bonus of £415 subject to your satisfactory compliance with the Volunteer Information sheet and Informed Consent, the Richmond Pharmacology Ltd Volunteer Charter (unit regulations) and all unit rules.
The total amount that you could be paid is £1240.
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Want to find out more?
If you are interested in finding out more visit http://www.trials4us.co.uk to register
Or
Call us free on 0800 085 64 64 and speak to a member of our Volunteer Recruitment Team.
A detailed information sheet is available on request.
9029_version 5_09 11 09
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Recommend a Friend
If you are not selected to take part in this study you could still earn money. Recommend a friend successfully to take part in this study, and once they have completed the study you could earn anything from £90 to £350!
Register now for more details!
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St George's and Mayday Hospitals
could earn between £90 - £350
also receive £5 for travel expenses
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