Recruiting for clinical study in May/June

CALL FOR STUDY VOLUNTEERS

P-One Clinic (Hachioji, Tokyo) is seeking male and female medical volunteers for an upcoming clinical study this May and June 2019.

WHAT ARE CLINICAL STUDIES?

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).

STUDY OUTLINE

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).

PARTICIPATION REQUIREMENTS

 

Inclusion Criteria
For this study, we are looking for individuals who meet all the conditions below:

  • Healthy white 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 either Japanese nationality or 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
Exclusion Criteria

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.

SCHEDULE

A) Screening & Information Session
Volunteers need only attend one screening to be considered for the study.

FOR MALE VOLUNTEERS
April 23rd (Tues) : 9:15 am (lasts approximately 3 hours)
Or
April 26th (Friday): 9:15 am (lasts approximately 3 hours) 

FOR FEMALE VOLUNTEERS
April 23rd (Tues) : 1:15 pm (lasts approximately 3 hours)
Or
April 26th (Friday): 1:15 pm (lasts approximately 3 hours)

B) Overnight Clinic Stays & Follow Up
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

2nd Clinic Stay: Tuesday May 28th- Saturday June 1st

3rd Clinic Stay: Tuesday June 11th- Saturday June 15th

Follow up: Tuesday June 25th (a health check in the morning for approximately 1 hour)

COMPENSATION

*All participants will be compensated for their time. Additional information will be provided to eligible volunteers.

HOW TO JOIN

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

ABOUT MVN & P-ONE CLINIC

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.

NOTE: Only eligible volunteers will be contacted. If you do not receive an email about this study, assume that you did not match the protocol requirements.

Please be Aware of the Following

  • Everyone who participates in a study (including any screenings) will be asked to present valid photo identification
  • Study cancellations or changes of schedule sometimes occur after you apply or take a screening
  • MVN is not able to respond to all inquiries
  • As mentioned in the MVN Membership Policy you will need to consent to before registering or applying, please understand that our staff will use the name and birthdate you provide to check whether you have participated in any other clinical studies and when the final dosing may have been conducted
  • Applying for multiple clinical studies simultaneously is not permitted. If you are discovered attempting multiple entry, your membership may be annulled.
  • If you are found to have made any false or fraudaulent statements, including those concerning your height/weight, medical history or previous study participation, you may be asked to leave without receiving the cooperation compensation