A Research Study on Etavopivat in Participants With and Without Liver Disease

Last updated: June 10, 2024
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

1

Condition

Primary Biliary Cholangitis

Treatment

Etavopivat

Clinical Study ID

NCT06336018
NN7535-7703
U1111-1289-2466
  • Ages > 18
  • All Genders

Study Summary

The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls). During the study, all participants will be given a single oral dose of etavopivat. All participants will take the etavopivat orally together with water. After dosing, the study will last for 7 to 9 days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female.

  • Age 18 years or above at the time of signing the informed consent.

  • Body mass index (BMI) between 18.5 and 42.0 kilogram per meter^2 (kg/m^2) (bothinclusive) at screening.

  • Body weight greater than or equal to (>=) 40.0 kilogram (kg) at screening.

Specific inclusion criteria only for participants with hepatic impairment:

  • Participants with chronic (above 6 months), stable (no significant deterioration inhepatic function in last 2 months as determined by the investigator) hepaticimpairment classified as Child-Pugh class A, B or C, as assessed by the investigatorand which is confirmed and documented by medical history, physical examination andat least one of the following: hepatic ultrasound, computerised axial tomography (CT) scan, magnetic resonance imaging (MRI), and/or liver biopsy.

  • Participants must be on a stable dose of medication and/or treatment regimen (e.g.,no expectations of new medications nor changes to current medications within 14 daysof dosing).

Specific inclusion criterion only for participants with normal hepatic function:

  • Considered to be generally healthy based on the medical history, physicalexamination, and the results of vital signs, electrocardiogram (ECG), and laboratorysafety tests performed during screening visit, as judged by the investigator.

Exclusion

Exclusion Criteria:

  • Known or suspected hypersensitivity to study intervention or related products.

  • Female who is pregnant, breast-feeding or intends to become pregnant or is ofchildbearing potential and not using adequate contraceptive methods.

  • Participation (i.e., signed informed consent) in any interventional clinical studywithin 30 days or 5 times the half-life of the previous investigational medicalproduct (IMP) (if known), whichever is longer, before screening.

  • Any disorder, unwillingness or inability, except for conditions associated withhepatic impairment in the group of participants with compromised hepatic function,which in the investigator's opinion might jeopardise participant's safety orcompliance with the protocol.

  • Participant is unable to refrain from or anticipates the use of, for 7 days prior todosing and throughout the study, any drug known to be:

  • an inhibitor of uridine 5'-diphospho-glucuronosyltransferase (UGT) 2B7,

  • a strong inhibitor of cytochrome P450 (CYP)3A4 or CYP2C9,

  • a potent inhibitor of permeability glycoprotein (P-gp).

  • Participant is unable to refrain from or anticipates the use of, for 28 days priorto dosing and throughout the study, any drug known to be:

  • an inducer of UGT2B7,

  • a strong or moderate inducer of CYP3A4, including St. John's Wort,

  • a strong inducer of CYP2C9,

  • a potent inducer of P-gp.

  • Participant is unable to refrain from or anticipates the use of any medications orsubstances prohibited in the study.

Specific exclusion criterion only for participants with hepatic impairment:

  • Clinical signs of an acute hepatitis (viral as well as non-viral) or positive testsof hepatitis B virus surface antigen (HBsAg) (unless hepatitis B virus titre isnegative) or antibody tests of hepatitis C virus (HCV-Ab) (unless negativepolymerase chain reaction [PCR] for hepatitis C virus).

Specific exclusion criteria only for participants with normal hepatic function:

  • Diagnostic test results positive for hepatitis B or hepatitis C infection.

  • History of diabetes mellitus or glycated haemoglobin (HbA1c) greater than or equalto 5 percent (48 millimoles per mole [mmol/mol]) at screening.

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Etavopivat
Phase: 1
Study Start date:
June 04, 2024
Estimated Completion Date:
September 04, 2025

Connect with a study center

  • Orlando Clinical Research Center

    Orlando, Florida 32809
    United States

    Active - Recruiting

  • Amer. Rrsch Corp-TX Liver Inst

    San Antonio, Texas 78215
    United States

    Active - Recruiting

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