P-One Clinic (Hachioji, Tokyo) is seeking male and female medical volunteers for an upcoming clinical study this May and June 2019.
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 (Apr 23rd or 26th). Volunteers who pass the screening will be invited to participate in a test of a drug. Starting in mid-May, they will stay at the clinic 3 times, for 4 nights each time, and return for a short follow up on June 25th (specific dates below).
For this study, we are looking for individuals who meet all the conditions below:
- Healthy male or female
- Aged 20 to 55 years at time of screening
- BMI (body mass index) 18.0 to 30.0 as measured at screening
- 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
If you meet any of the following conditions, you cannot participate in the study:
- You have a serious physical or psychological condition or a history of such a condition
- You test positive on either the drug or alcohol test at the screening or the day before dosing
- You test positive for hepatitis B, hepatitis C, syphilis, or HIV at the screening
- You smoked/consumed any nicotine containing product (including cigarettes, cigars, vapes, the patch, nicotine gum etc.) within 26 days prior to the day before dosing
- You took over the counter or prescription medicine (including traditional Japanese medicine, vitamins, minerals, herbs, and supplements) within 2 weeks prior to the day before dosing
- You participated in another study within 28 days prior to the day before dosing
*Please note: these are only a summary of the main requirements. Additional details will be provided to eligible volunteers.
Volunteers need only attend one screening to be considered for the study.
April 23rd (Tues) : 9:15 am (lasts approximately 3 hours)
Or
April 26th (Friday): 9:15 am (lasts approximately 3 hours)
April 23rd (Tues) : 1:15 pm (lasts approximately 3 hours)
Or
April 26th (Friday): 1:15 pm (lasts approximately 3 hours)
Volunteers will attend all three clinic stays and a final follow up, with 10 days between each. For all stays, volunteers will be admitted to the clinic on the afternoon of the first day, take the drug on the second day, and be released in the early afternoon on the final day.
1st Clinic Stay: Tuesday May 14th – Saturday May 18th
*All participants will be compensated for their time. Additional information will be provided to eligible volunteers.
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 info@medical-volunteer-network.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. In the 13 years since P-One Clinic was established in 2005, it has completed over 200 studies and has been conducting studies with non-Japanese volunteers since 2011.