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An Open-label, Single-dose Study for the Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Safety of KP-001
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.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Sites contracted by Parexel
San Antonio, Texas, United States
Start Date
October 24, 2024
Primary Completion Date
May 16, 2025
Completion Date
July 31, 2025
Last Updated
October 31, 2025
24
ACTUAL participants
KP-001
DRUG
Lead Sponsor
Kaken Pharmaceutical
NCT07324616
NCT07227259
NCT06815991
Data Source & Attribution
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