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

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
NewAmsterdam Pharma
Study ID
NCT06048302
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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).

Key Dates

Start date
Nov 30, 2023
Status verified
Sep 2024
Primary completion
Mar 12, 2024
Completion
Mar 19, 2024

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Active Comparitor: Subjects with Moderate Hepatic Impairment
    8 patients with hepatic impairment of moderate Child Pugh Category
  • Other: Active Comparator: Healthy Subjects
    Healthy volunteers will be matched with impaired hepatic function patients

Primary Outcome Measure

Area under the curve from dosing time to infinity (AUC (0-inf)) for obicetrapib [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Nucleus NetworkSaint PaulMinnesota55114-
The American Research CorporationSan AntonioTexas78215-

Find similar trials in Saint Paul, MN

By research site
Nucleus Network· Saint Paul, MNThe American Research Corporation· San Antonio, TX

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