P-One Clinic (Hachioji, Tokyo) is seeking female participants for an upcoming clinical study this January and February 2020.
Clinical studies (also called “clinical trials”) are scientific tests to check the efficacy and safety of new drugs, medical devices, and healthcare procedures. They are conducted with the cooperation of willing volunteers and governed by the strict legal and ethical guidelines of Good Clinical Practice (GCP). By participating in a clinical study, you play a crucial role in helping to get new medicines to the patients who need them.
Those who pass the initial selection will be invited to an information/consent session and screening health check (Feb 18th or 25th). Volunteers who pass the screening will be invited to participate in a test of a drug. They will stay at the clinic for 3 nights in mid March (dates yet to be decided) and return for a total of six short visits (specific dates below).
SUMMARY OF PARTICIPATION REQUIREMENTS
Basic Inclusion Criteria
For this study, we are looking for individuals who meet ALL the conditions below:
- Female aged 20 to 64 years at time of screening
- Healthy based on medical history and testing/examinations at the screening
- BMI (body mass index) no more than 30.0
- You are living in Japan with a valid residence card
- Your test results and medical background at the screening and on the day before dosing are suitable for the study
- Willing to consent to the study and able to abide by study requirements
Special Inclusion Criteria
Participants must not be of childbearing potential (i.e. not capable of becoming pregnant). To be considered not of childbearing potential, you must match ONE of the following conditions:
- You are postmenopausal. That is, you have not had your period for at least 12 months due to the onset of menopause.
- You are premenopausal but you are infertile for some documented medical reason such as: a) hysterectomy (removal of uterus), b) bilaterial salpingectomy (removal of both Fallopian tubes ), or c) bilateral oophorectomy (removal of both ovaries).
*Please note: these are only a summary of the main requirements.
A) Screening & Information Session
Feb 18 (Tues) : 9:15 am (lasts approximately 3 hours)
Feb 25 (Tues): 9:15 am (lasts approximately 3 hours)
*All participants must attend one of the two screenings. Those who pass will be invited to stay overnight at the clinic
Overnight Clinic Stay (CURRENTLY TENTATIVE, DATES MAY CHANGE)
Mar 5 (Thu) – Mar 8 (Sun)
*Volunteers will be admitted to the clinic on March 5 and released on March 8 for a three night stay. (The study drug will be administered on March 6).
**All participants who take the study drug will be required to return to the clinic for 6 visits
Schedule for Clinic Visits (CURRENTLY TENTATIVE, DATES MAY CHANGE)
After the clinic stay, participants will be asked to visit the clinic to take basic health checks (in the morning, usually about 1 hour) a total of 6 times. The dates are as follows:
Visit 1: Mar 9 (Mon)
Visit 2: Mar 10 (Tues)
Visit 3: Mar 11 (Wed)
Visit 4: Mar 13 (Fri)
Visit 5: Mar 20 (Fri)
Visit 6 (final follow up): Mar 27 (Fri)
*All participants will be compensated for their transportation and time. Please email us or apply for details.
If you interested in joining this study, the first step is to register with MVN. Click the button below for our registration page. For questions, email email@example.com
Medical Volunteer Network (MVN) connects non-Japanese volunteers with P-One Clinic, a medical research center in western Tokyo that specializes in clinical studies. Since P-One Clinic was established in 2005, it has completed over 200 studies and more than a dozen with non-Japanese volunteers.