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Single-dose Study to Investigate the Plasma PK of KW-6356 and Its Major Metabolite

NCT04190654 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-04-25

No results posted yet for this study

Summary

This is an open-label, non-randomized, single-dose study to investigate the plasma PK of KW-6356 and its major metabolite, after a single oral dose of KW-6356, in subjects with mild or moderate hepatic impairment and in healthy adults

Conditions

  • Hepatic Impairment

Interventions

DRUG

KW-6356

Single oral dose of KW-6356

Sponsors & Collaborators

  • Kyowa Kirin, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-26
Primary Completion
2020-03-20
Completion
2020-03-20
FDA Drug
Yes

Countries

  • United States

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 NCT04190654 on ClinicalTrials.gov