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

Last updated: September 14, 2024
Sponsor: NewAmsterdam Pharma
Overall Status: Completed

Phase

1

Condition

Primary Biliary Cholangitis

Treatment

Obicetrapib

Clinical Study ID

NCT06048302
TA-8995-12
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A male or a female of non-childbearing potential.

  • Women of childbearing potential (WOCBP) must have a negative serum beta-humanchorionic gonadotropin (β-hCG) pregnancy test at the Screening Visit.

  • Body mass index (BMI) of 17.5 to 42 kg/m2; with a total body weight >50 kg (110 lb).

  • Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the ICF and in this protocol.

  • Willing and able to comply with all scheduled visits, treatment plan, laboratorytests, lifestyle considerations, and other study procedures.

  • Cohort 1: Meet the criteria for Class B (moderate hepatic impairment) of themodified CPC. A diagnosis of hepatic dysfunction due to hepatocellular disease (andnot secondary to any acute ongoing hepatocellular process) documented by medicalhistory, physical examination (PE), liver biopsy, hepatic ultrasound, computerizedtomography scan, or magnetic resonance imaging.

  • Cohort 2: Will only enroll healthy volunteers with no hepatic impairment. "Healthy"is defined as no clinically relevant abnormalities identified by a detailed medicalhistory, complete PE (including blood pressure [BP] and pulse rate measurement), 12-lead ECG or clinical laboratory tests performed during Screening.

Exclusion

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (e.g., gastrectomy). Uncomplicatedcholecystectomy is allowed.

  • History of or current positive results for human immunodeficiency virus (HIV)infection, hepatitis B virus (HBV) or hepatitis C virus (HCV), including hepatitis Bsurface antigen (HbsAg) or hepatitis C Virus antibody (HCVAb).

  • Other medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the Investigator's judgment, make the participantinappropriate for participation in the study.

  • Participants with an estimated glomerular filtration rate (eGFR) value of ≤30mL/min/1.73 m2, based on the 2021 Chronic Kidney Disease Epidemiology Collaborationequation during Screening. A single repeat assessment is permitted to assesseligibility, if needed.

  • Previous administration of drugs or supplements known to be strong inducers orinhibitors of CYP3A4 within 7 days of planned dosing of obicetrapib on Day 1.

  • Concurrent use of drugs or supplements that are known substrates of CYP3A that havenarrow therapeutic indices (e.g., alfentanil, cyclosporine, dihydroergotamine,ergotamine, fentanyl including transdermal patch, pimozide, quinidine, sirolimus,tacrolimus) within 12 days prior to planned dosing of obicetrapib on Day 1.

  • Participants on oral contraceptives and hormonal based contraceptives includingimplantable, intrauterine, intravaginal, transdermal or injectable form.

  • Previous administration of an investigational drug within 30 days (or as determinedby the local requirement) or within 5 half-lives of that investigational drug, priorto planned dosing of obicetrapib on Day 1.

  • Known hypersensitivity to obicetrapib or its excipients.

  • A positive urine drug test. Participants with moderate hepatic impairment (Cohort 1)will be eligible to participate if their urine drug test is positive with a drug fora prescribed condition that is not expected to interfere with the PK of obicetrapib.Positive urine drug tests for tetrahydrocannabinol (THC) will be allowed as long asthe volunteer agrees to abstain from ingesting any THC-containing products for theduration of the study (including Out patient visits up to Day 28).

  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or morewithin 60 days prior to planned dosing of obicetrapib on Day 1.

  • History of sensitivity to heparin or a history of heparin-induced thrombocytopenia.

  • Unwilling or unable to comply with the criteria in the Lifestyle considerationslisted in the protocol.

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Obicetrapib
Phase: 1
Study Start date:
November 30, 2023
Estimated Completion Date:
March 19, 2024

Study 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.

Connect with a study center

  • Nucleus Network

    Saint Paul, Minnesota 55114
    United States

    Site Not Available

  • The American Research Corporation

    San Antonio, Texas 78215
    United States

    Site Not Available

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