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

Description

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.

Conditions

Liver Diseases

Study Overview

Study Details

Study overview

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.

A Multi-centre, Open-label, Parallel-group Study Investigating the Pharmacokinetics, Safety and Tolerability After a Single Dose of Oral Etavopivat in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Participants With Normal Hepatic Function

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

Condition
Liver Diseases
Intervention / Treatment

-

Contacts and Locations

Orlando

Orlando Clinical Research Center, Orlando, Florida, United States, 32809

San Antonio

Amer. Rrsch Corp-TX Liver Inst, San Antonio, Texas, United States, 78215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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) (both inclusive) at screening.
  • * Body weight greater than or equal to (\>=) 40.0 kilogram (kg) at screening.
  • * Participants with chronic (above 6 months), stable (no significant deterioration in hepatic function in last 2 months as determined by the investigator) hepatic impairment classified as Child-Pugh class A, B or C, as assessed by the investigator and which is confirmed and documented by medical history, physical examination and at 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 days of dosing).
  • * Known or suspected hypersensitivity to study intervention or related products.
  • * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods.
  • * Participation (i.e., signed informed consent) in any interventional clinical study within 30 days or 5 times the half-life of the previous investigational medical product (IMP) (if known), whichever is longer, before screening.
  • * Any disorder, unwillingness or inability, except for conditions associated with hepatic impairment in the group of participants with compromised hepatic function, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • * Participant is unable to refrain from or anticipates the use of, for 7 days prior to dosing 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 prior to 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 or substances prohibited in the study.
  • * Diagnostic test results positive for hepatitis B or hepatitis C infection.
  • * History of diabetes mellitus or glycated haemoglobin (HbA1c) greater than or equal to 5 percent (48 millimoles per mole \[mmol/mol\]) at screening.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novo Nordisk A/S,

Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

2025-09-04