NCT06619054

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001

An Open-label, Single-dose Study for the Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Safety of KP-001

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Kaken Pharmaceutical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, open-label, non-randomized, parallel-group, single-dose study to assess the effect of hepatic impairment (assessed by the criteria of the Child-Pugh scale) on the pharmacokinetics (PK) and safety of KP-001 in adult male and non-childbearing potential female participants aged ≥20 years old. The purpose of this study is to evaluate the effect of hepatic impairment on the PK and safety of KP-001. The study will also assess the effect of hepatic impairment on other PK parameters after single dose administration of KP-001. The study will comprise 3 parts, and the study period for each part will consist of the following: * Screening period: Up to 28 days before the administration of study intervention * Treatment Period: Participants will be residential at the Clinical Unit from the day before the administration of the single dose of KP-001 (Day -1) until Day 3 (Discharge) * Follow-up Visit: 7 days after discharge from the Clinical Unit (ie, Day 10) Participants will be enrolled into 4 cohorts according to the hepatic function status as summarized below. The study includes a control group of healthy participants with normal hepatic function.

Conditions

• Healthy Adults
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	KP-001	Oral single dose 50mg.

Timeline

• Start date: 2024-10-24
• Primary completion: 2025-05-16
• Completion: 2025-07-31
• First posted: 2024-10-01
• Last updated: 2025-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study