Single Dose Phase I Study of FYU-981

NCT ID: NCT02348307

Last Updated: 2015-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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FYU-981

Group Type ACTIVE_COMPARATOR

FYU-981, (Oral single dosing)

Intervention Type DRUG

Subjects randomized to the FYU-981 arm receive active drug, FYU-981.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo, (Oral single dosing)

Intervention Type DRUG

Subjects randomized to the placebo arm receive placebo.

Interventions

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FYU-981, (Oral single dosing)

Subjects randomized to the FYU-981 arm receive active drug, FYU-981.

Intervention Type DRUG

Placebo, (Oral single dosing)

Subjects randomized to the placebo arm receive placebo.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fuji Yakuhin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Japan

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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FYU-981-001

Identifier Type: -

Identifier Source: org_study_id

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