NCT04190654

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

A Pharmacokinetic Study of KW-6356 in Subjects With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Detailed description

Potential subjects will be screened to assess their eligibility to enter the study within 4 weeks prior to dose administration. Eligible subjects will be admitted to the clinical research unit (CRU) before the initiation of investigational medicinal product (IMP) administration (Check-in/Day -1) and administered of KW-6356 orally on Day 1 after an 8-hour fast. Those subjects who complete all the scheduled observations/examinations and are determined to have no clinical abnormalities requiring further hospitalization by the Investigator, will be discharged from the study site on Day 4. Discharged subjects will then visit the CRU on the scheduled visit Days 5, 6, 7, 8 for PK sample collections and safety assessments on Day 12 to complete the End of Study (EOS) visit. The duration of hospitalization will be 5 days: 4 nights from Day -1 to Day 4.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	KW-6356	Single oral dose of KW-6356

Timeline

• Start date: 2019-11-26
• Primary completion: 2020-03-20
• Completion: 2020-03-20
• First posted: 2019-12-09
• Last updated: 2024-04-25

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study