NCT06048302

PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function

A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Plasma Pharmacokinetics and Safety of Obicetrapib in Participants With Moderate Hepatic Impairment Relative to Participants With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: NewAmsterdam Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To investigate the safety and pharmacokinetics in patients with moderate hepatic impairment compared to healthy participants after a single oral dose of obicetrapib (10 mg).

Detailed description

This is a Phase 1, open-label, single-dose, parallel-group study to evaluate the plasma PK and safety of obicetrapib in participants with moderate hepatic impairment relative to participants with normal hepatic function. The purpose of the study is to investigate the effect of moderate hepatic impairment on obicetrapib PK and safety in otherwise healthy participants after a single oral 10 mg dose of obicetrapib.

Conditions

• Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	Obicetrapib	1 single dose of obicetrapib

Timeline

• Start date: 2023-11-30
• Primary completion: 2024-03-12
• Completion: 2024-03-19
• First posted: 2023-09-21
• Last updated: 2024-09-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study