KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatic Impairment
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Open-label, non-randomized, parallel-group study with the following subject treatment arms: Group 1: normal hepatic function; Group 2: mild hepatic impairment; Group 3: moderate hepatic impairment; Group 4: severe hepatic impairmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 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.
Tracking Information
- NCT #
- NCT04166942
- Collaborators
- Not Provided
- Investigators
- Study Director: Olivier Schueller Kadmon Corporation
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