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Clinical Pharmacology of FYU-981 (Final Formulation)

NCT ID: NCT03350373

Last Updated: 2017-12-12

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2017-11-29

Brief Summary

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This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics 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

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fasted dosing followed by fed dosing

Dosing of FYU-981 in the fasted state followed by fed dosing

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Single administration of FYU-981 under Fasted and fed conditions in the morning.

Fed dosing followed by fasted dosing

Dosing of FYU-981 in the fed state followed by fasted dosing

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Single administration of FYU-981 under Fasted and fed conditions in the morning.

Interventions

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FYU-981

Single administration of FYU-981 under Fasted and fed conditions in the morning.

Intervention Type DRUG

Other Intervention Names

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Final formulation of FYU-981

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 collaborator

Mochida Pharmaceutical Company, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katsuaki Nagasawa

Role: STUDY_DIRECTOR

Clinical Research Department

Locations

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P-One Clinic

Hachiōji, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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FYU-981-016

Identifier Type: -

Identifier Source: org_study_id