Recruiting for new clinical study, 3 nights in mid November 2018

CALL FOR STUDY VOLUNTEERS

P-One Clinic (Hachioji, Tokyo) is seeking volunteers for an upcoming clinical study in mid November 2018. See below for details.

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 register and pass the initial selection will be invited to an information/consent session and screening health check (Oct 29 or Nov 1) at P-One Clinic. Volunteers that pass the screening will be invited to participate in a test of a drug. They will join one of 3 study groups who will stay at the clinic for 3 nights in mid November and return several days later for a short follow up (specific dates below).

PARTICIPATION REQUIREMENTS
Inclusion Criteria
For this study, we are looking for individuals who meet all the conditions below:
  • Healthy male aged 20 years to 45 years at time of screening
  • BMI (body mass index) 18.0 to 30.0, and body weight 50 kg or more
  • You are living in Japan with either Japanese nationality or a valid residence card
  • You are willing to use an appropriate method of contraception (condoms etc.) for the two weeks of the study period
  • You are willing to refrain from taking all medications/drugs and supplements from at least 1 week prior to study drug administration
  • You are willing to refrain from consuming caffeine, xanthine, alcohol, grapefruits, grapefruit juice, tobacco, nicotine, or any product containing any of these from 24 hours before the study and during the study
Exclusion Criteria

If you meet any of the following conditions, you cannot participate in the study:

  • You have a serious disease or a history of being treated for such a disease
  • You have a history of allergies to drugs or food
  • You participated in another study and took a different study drug within 12 weeks prior to the screening for this study
  • You have a history of drug or alcohol abuse or addiction

*Please note: these are only a summary of the main requirements. Please register for further details.

SCHEDULE
Screening & Information Session
10/29 (Mon) : 9:15 am (lasts approximately 3 hours)
OR
11/1 (Thu): 9:15 am (lasts approximately 3 hours)
※Volunteers need only attend one

Overnight Clinic Stay & Follow Up
Those who pass the screening will be invited to join ONE of the following study groups and stay at P-One Clinic for 4 days (3 nights). For all groups, volunteers will be admitted to the clinic on the afternoon of the first day, take the drug on the second day, and be released on the afternoon of the final day. They will then return five days later for a follow up.

Group 1 Schedule

Clinic stay: 11/13 (Tue) – 11/16 (Fri)
+
Follow up: 11/21 (Wed)

Group 2

Clinic stay: 11/16 (Fri) – 11/19 (Mon)
+
Follow up: 11/24 (Sat)

Group 3

Clinic stay: 11/19 (Mon) – 11/22 (Thu)
+
Follow up: 11/27 (Tue)

COMPENSATION

All volunteers will be compensated for their transportation and time. Please apply for further details.

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.

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