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

Novo Nordisk

Status and phase

Enrolling

Phase 1

Conditions

Liver Diseases

Treatments

Drug: Etavopivat

Study type

Interventional

Funder types

Industry

Identifiers

NCT06336018

U1111-1289-2466 (Other Identifier)

NN7535-7703

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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) (both inclusive) 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 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).

Specific inclusion criterion only for participants with normal hepatic function:

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

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 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.

Specific exclusion criterion only for participants with hepatic impairment:

Clinical signs of an acute hepatitis (viral as well as non-viral) or positive tests of hepatitis B virus surface antigen (HBsAg) (unless hepatitis B virus titre is negative) or antibody tests of hepatitis C virus (HCV-Ab) (unless negative polymerase 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 equal to 5 percent (48 millimoles per mole [mmol/mol]) at screening.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 5 patient groups

Mild hepatic impairment: Etavopivat dose 2

Experimental group

Description: