Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-06

Study Completion Date

2018-06-25

Brief Summary

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The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.

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Detailed Description

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Conditions

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Hepatic Insufficiency Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Normal group

Healthy control subjects

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Oral single dosing

Mild hepatic-insufficient group

Patients with mild hepatic impaired function (Child-Pugh A)

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Oral single dosing

Moderate hepatic-insufficient group

Patients with moderate hepatic impaired function (Child-Pugh B)

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Oral single dosing

Severe hepatic-insufficient group

Patients with severe hepatic impaired function (Child-Pugh C)

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Oral single dosing

Interventions

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FYU-981

Oral single dosing

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult healthy subjects or adult cirrhosis patients
* Body mass index: \>=18.5 and \<30.0

Exclusion Criteria

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study (except for cirrhosis patients with hepatic diseases)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes