Richmond Pharmacology - UK Clinical Trial Volunteer Recruitment
Ongoing Trials
Are you a healthy female aged 20 to 40?
Have you ever wondered how the safety of new medicines currently on the market is researched? Would you like to be part of that process and do something good today?
- What is this all about?
We have been asked to undertake a study in healthy Caucasian and Japanese female volunteers aged between 20 and 40 (inclusive).
The main aim of this study is to see what affect the body has on the study drug, KLH-2109, to assess how well the body tolerates KLH-2109 following the administration of single and multiple ascending doses, and to see if there are any side effects. We will also investigate the possible food interaction following a single oral dose of the study drug.
KLH-2109 has been developed for the treatment of endometriosis, a condition where cells like the ones in the lining of the womb are found growing elsewhere in the body, most commonly on the ovaries. The symptoms of endometriosis include painful, heavy or irregular monthly periods and pelvic pain. Endometriosis can be difficult to treat and so the aim of investigational treatment (KLH-2109) is to manage the condition and to relieve the pain which often worsens in time with the menstrual cycle.
KLH-2109 is not available on prescription or as an over-the-counter medication. The study drug has never been given to humans before and as such this is a first into man trial.
We are looking for healthy pre-menopausal Caucasian and Japanese females aged 20 to 40 (inclusive).
The main aim of this study is to see what affect the body has on the study drug, KLH-2109, to assess how well the body tolerates KLH-2109 following the administration of single and multiple ascending doses, and to see if there are any side effects. We will also investigate the possible food interaction following a single oral dose of the study drug.
KLH-2109 has been developed for the treatment of endometriosis, a condition where cells like the ones in the lining of the womb are found growing elsewhere in the body, most commonly on the ovaries. The symptoms of endometriosis include painful, heavy or irregular monthly periods and pelvic pain. Endometriosis can be difficult to treat and so the aim of investigational treatment (KLH-2109) is to manage the condition and to relieve the pain which often worsens in time with the menstrual cycle.
KLH-2109 is not available on prescription or as an over-the-counter medication. The study drug has never been given to humans before and as such this is a first into man trial.
We are looking for healthy pre-menopausal Caucasian and Japanese females aged 20 to 40 (inclusive).
- Who is suitable for this study?
To qualify for participation you need to:
- Be a healthy pre-menopausal Caucasian or Japanese female aged 20 to 40 (inclusive).
- Be a non-smoker, i.e. you have not smoked in the past 6 months.
- 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.
- Have a Body Mass Index (BMI) is between 18-28 kg/m2, inclusive (your BMI is calculated using the formula: weight (in kilograms) divided by height (in metres) squared).
- Have a regular menstrual cycle (monthly period, 28 days +/- 2 days) for at least one year – the Research Doctor will ask you about your menstrual cycle.
- You must have a negative pregnancy test at screening and at admission on Day -2 to the unit, and you must agree to use acceptable methods of contraception.
- If you are of childbearing potential, you must use medically acceptable methods of contraception from the time of the administration of the study drug until 3 months following administration.
By acceptable methods of contraception we mean:
- 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};
- 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.
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 two screening visits; the first between 27-60 days prior to the first dose of study medication (Day 1) and the second between 3-30 days prior to Day 1.
If you pass the screening visit you will be invited to take part in the study.
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 two screening visits; the first between 27-60 days prior to the first dose of study medication (Day 1) and the second between 3-30 days prior to Day 1.
If you pass the screening visit you will be invited to take part in the study.
- Study Participation
Participation requires you to stay at our clinical unit for one residential stay of 13 days and 12 nights. In addition, you will need to attend the unit for a follow-up visit which will be scheduled 7 to 14 days after the last dose of the study drug.
Study dates for each group visit are listed as follows:
Groups 2-3
Admissions: September/October 2010
Dismissal: 13 days from date of admission
Follow-up visit: 7 to 14 days after the last dose of the study drug
Study dates for each group visit are listed as follows:
Groups 2-3
Admissions: September/October 2010
Dismissal: 13 days from date of admission
Follow-up visit: 7 to 14 days after the last dose of the study drug
- What’s in it for you?
You will receive £1,040 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 £520 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).
***PLUS receive up to £900 extra as a compliance bonus if you fill out your diary card correctly:
In addition, between Screening 1 and the day of admissions you will receive an extra compliance bonus of £30 per day starting from the first day of your menstrual cycle until the day that you are admitted onto the study. Payment of the compliance bonus will be made on Day 1 (first dosing day of the study) and based on the following:
- If you have completed Screening Visits 1 and 2, completed your diary card correctly and admitted onto the study.
- If you have completed Screening Visits 1 and 2, completed your diary card correctly but are rejected due to unforeseeable reasons. If this happens to you, you will receive the bonus based on pro rata, based on the time spent monitoring your menstrual cycle following Screening 1 up to a maximum of the start of your cycle, i.e. the date of your admission.
However, if you complete Screening Visits 1 and 2, complete your diary card but withdraw consent, no bonus will be paid to you.
The total amount that you could be paid:
|
|
|
|
|
26 |
£780 |
£2340 |
|
27 |
£810 |
£2370 |
|
28 |
£840 |
£2400 |
|
29 |
£870 |
£2430 |
|
30 |
£900 |
£2460 |
The total amount that you could be paid for participation is up to £2,460 (£1560 + up to £900 for the diary card compliance bonus). This payment includes all travel expenses.
- Want to find out more?
If you are interested in finding out more Click
here 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.
No deductions will be made for Tax and insurance, it will be your own responsibility to report the payment to the relevant authorities.
If you are in receipt of any benefits, the payment you receive for taking part in this study may affect your eligibility to those benefits.
On occasion, we are required by law to disclose such payments when requested
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.
No deductions will be made for Tax and insurance, it will be your own responsibility to report the payment to the relevant authorities.
If you are in receipt of any benefits, the payment you receive for taking part in this study may affect your eligibility to those benefits.
On occasion, we are required by law to disclose such payments when requested
Ref:
KS1
Web_Story_9070_version 3_29 07 10.doc
Register now for more details!
Are you a healthy male or female aged 20-60?
- What is this all about?
We have been asked to undertake a study in healthy Caucasian and Japanese male and female volunteers aged between 20 and 60 (inclusive).
Debio 025 is an investigational new drug that is being developed for the treatment of hepatitis C. The symptoms of acute hepatitis C include decreased appetite, fatigue (tiredness), abdominal pain, jaundice (the skin appears yellow), itching, and flu-like symptoms. Chronic hepatitis C is associated with serious complications which lead to liver disease. Hepatitis C is caused by the hepatitis C virus (HCV) against which Debio 025 has been shown to have anti-HCV properties.
It is anticipated that Debio 025 may have some advantage compared to other drugs (antivirals) which are currently used in medical practice. Debio 025 has a different mode of action, which may allow for a greater response against the different HCV genotypes.
The main aim of this study is to see what affect the body has on the study drug, Debio 025, to assess how well the body tolerates Debio 025 following the administration of single and multiple ascending doses, and to see if there are any side effects. We will also investigate the possible food interaction following a single oral dose of the study drug.
We are looking for healthy Caucasian males and females aged 20 to 60 (inclusive).
Debio 025 is an investigational new drug that is being developed for the treatment of hepatitis C. The symptoms of acute hepatitis C include decreased appetite, fatigue (tiredness), abdominal pain, jaundice (the skin appears yellow), itching, and flu-like symptoms. Chronic hepatitis C is associated with serious complications which lead to liver disease. Hepatitis C is caused by the hepatitis C virus (HCV) against which Debio 025 has been shown to have anti-HCV properties.
It is anticipated that Debio 025 may have some advantage compared to other drugs (antivirals) which are currently used in medical practice. Debio 025 has a different mode of action, which may allow for a greater response against the different HCV genotypes.
The main aim of this study is to see what affect the body has on the study drug, Debio 025, to assess how well the body tolerates Debio 025 following the administration of single and multiple ascending doses, and to see if there are any side effects. We will also investigate the possible food interaction following a single oral dose of the study drug.
We are looking for healthy Caucasian males and females aged 20 to 60 (inclusive).
- Who is suitable for this study?
- Be a healthy Caucasian male or female aged 20 to 60 (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 from safety blood and urine tests, physical examination, ECG and 24-hour heart monitoring.
- Have a Body Mass Index (BMI) is between 18-23 kg/m2, inclusive (your BMI is calculated using the formula: weight (in kilograms) divided by height (in metres) squared).
- Smoke less than 10 cigarettes per day or if you are using nicotine containing products, (i.e. equivalent to less than 10 cigarettes per day) you must be able stop using these products during your stay within the clinical unit.
- 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.
For female volunteers:
If you are female of childbearing potential, you must have a negative pregnancy test at screening and at admission on Day -2 to the unit. You may participate if you are not of childbearing potential (documented sterilisation or postmenopausal) or practice TWO of the following effective forms of contraception:
- documented placement of intrauterine device/system
- use of condom/occlusive cap with spermicide
- documented male partner sterilisation
- abstinence
For male volunteers:
You must be surgically sterile or ensure that your partner/spouse is not of childbearing potential (documented sterilisation or post-menopausal) or practices TWO of the following effective forms of contraception:
- documented placement of intrauterine device/system
- use of condom/occlusive cap with spermicide
- use of hormonal contraception
- abstinence
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 up to 21 days before the start of the study. If you pass the screening visit you will be invited to take part in the study.
- Study Participation
Study dates for each group visit are listed as follows:
Group 2
1st Visit
Admissions: Sunday, 12 September 2010
Dismissal: Friday, 17 September 2010
2nd Visit
Admissions: Sunday, 3 October 2010
Dismissal: Wednesday, 13 October 2010
Follow-up Visits
7 external visits scheduled from Days 8 to 64 and a final follow-up visit scheduled 53-57 days after the last dose of the study drug.
Group 3
1st Visit
Admissions: Sunday, 26 September 2010
Dismissal: Friday, 1 October 2010
2nd Visit
Admissions: Sunday, 17 October 2010
Dismissal: Wednesday, 27 October 2010
Follow-up Visits
7
external visits scheduled from Days 8 to 64 and a final follow-up visit
scheduled 53-57 days after the last dose of the study drug.
- 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.
You will receive £1,854 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 £926 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 participation is £2,780. This payment includes all travel expenses.
You will receive £1,854 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 £926 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 participation is £2,780. This payment includes all travel expenses.
- Want to find out more?
If you are interested in finding out more Click
here 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.
Ref: DP 1
Web_Story_1009_version 1_PART 1 14 06 10.doc
Register now for more details!
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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See info about ongoing trials at
St George's and Mayday Hospitals
St George's and Mayday Hospitals
Recommend a friend and you
could earn between £90 - £350
could earn between £90 - £350
Give blood for up to £100 and
also receive £5 for travel expenses
also receive £5 for travel expenses
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