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).
Those who pass the initial selection will be invited to an information/consent session and screening health check (Jan 15th or 23rd). Candidates who pass the screening will be invited to participate in a test of a drug. They will stay at the clinic for 3 nights (Feb 11th-14th) 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
Jan 15 (Wed) : 9:15 am (lasts approximately 3 hours)
Jan 23 (Thu): 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
Feb 11 (Tues) – Feb 14 (Fri)
*Participants will be admitted to the clinic on February 11 and released on February 14 for a three night stay. (The study drug will be administered on Feb 12).
**All participants who take the study drug will be required to return to the clinic for 6 visits
Schedule for Clinic Visits
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: Feb 15 (Sat)
Visit 2: Feb 16 (Sun)
Visit 3: Feb 17 (Mon)
Visit 4: Feb 19 (Wed)
Visit 5: Feb 26 (Wed)
Visit 6 (final follow up): Mar 4 (Wed)
*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 firstname.lastname@example.org
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 10 with non-Japanese volunteers.