Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT06048302
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function
Sponsor:
NewAmsterdam Pharma
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: