NCT04166942

KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment

A Single-dose, Open-label, Pharmacokinetic Study of KD025 in Subjects With Normal Hepatic Function & Subjects With Varying Degrees of Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Kadmon, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a study to characterize the pharmacokinetics, safety and tolerability of KD025 and KD025 metabolites in subjects with mild, moderate or severe hepatic impairment compared to healthy subjects with normal hepatic function.

Detailed description

The primary objective of the study is: • To assess the pharmacokinetics (PK) of KD025 following a single oral dose of KD025 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function. The secondary objectives of the study are: * To evaluate the safety and tolerability of a single oral dose of KD025 in subjects with mild, moderate, or severe hepatic impairment, and in healthy subjects with normal hepatic function. * To assess the PK of the KD025 metabolites following a single oral dose of KD025 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	KD025	Single dose of 200 mg KD025 orally

Timeline

• Start date: 2019-12-11
• Primary completion: 2022-06-06
• Completion: 2022-06-06
• First posted: 2019-11-18
• Last updated: 2022-07-18

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study