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

NCT03306667 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-09-24

No results posted yet for this study

Summary

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.

Conditions

  • Hepatic Insufficiency
  • Healthy

Interventions

DRUG

FYU-981

Oral single dosing

Sponsors & Collaborators

  • Fuji Yakuhin Co., Ltd.

    collaborator INDUSTRY

  • Mochida Pharmaceutical Company, Ltd.

    lead INDUSTRY

Principal Investigators

  • Shigeki Matsumoto · Clinical Research Department

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-06
Primary Completion
2018-06-20
Completion
2018-06-25

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03306667 on ClinicalTrials.gov