Single Dose Phase I Study of FYU-981

January 22, 2015 updated by: Fuji Yakuhin Co., Ltd.

Single Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in fasted and fed conditions. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered. The effect of food on PK/PD of FYU-981 is also investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Japanese healthy adult subjects
  • Body mass index: >=18.5 and <25.0

Exclusion Criteria:

  • Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo, (Oral single dosing)
Subjects randomized to the placebo arm receive placebo.
Active Comparator: FYU-981
Drug: FYU-981, (Oral single dosing)
Subjects randomized to the FYU-981 arm receive active drug, FYU-981.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time Frame: 48 hours
48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time Frame: 48 hours
48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time Frame: 48 hours
48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time Frame: 48 hours
48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time Frame: 48 hours
48 hours
Pharmacokinetics (kel: Elimination rate constant)
Time Frame: 48 hours
48 hours
Pharmacokinetics (MRT: Mean residence time)
Time Frame: 48 hours
48 hours
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Time Frame: 48 hours
48 hours
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Time Frame: 48 hours
48 hours
Pharmacokinetics (CLr: Renal clearance)
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuji Yakuhin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

January 18, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Estimate)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FYU-981-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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