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

NCT06336018 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN7535-7703U1111-1289-2466
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (2)

• Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose (AUC0-inf, etavopivat)

  Measured in hours\*nanogram per milliter (h\*ng/mL).

  From IMP administration on day 1 to completion of the end of study visit (day 9)

• Maximum observed etavopivat plasma concentration after a single dose (Cmax, etavopivat)

  Measured in nanogram per milliter (ng/mL).

  From IMP administration on day 1 to completion of the end of study visit (day 9)

Secondary Outcomes (6)

• Area under the etavopivat plasma concentration-time curve from 0 hours to the last quantifiable concentration after a single dose (AUC0-last, etavopivat)

  From IMP administration on day 1 to completion of the end of study visit (day 9)

• Time to maximum observed etavopivat plasma concentration after a single dose (tmax, etavopivat)

  From IMP administration on day 1 to completion of the end of study visit (day 9)

• Terminal half-life for etavopivat after a single dose (t1/2, etavopivat)

  From IMP administration on day 1 to completion of the end of study visit (day 9)

• Apparent plasma clearance of etavopivat after a single dose (CL/Fetavopivat)

  From IMP administration on day 1 to completion of the end of study visit (day 9)

• Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values (Vz/Fetavopivat)

  From IMP administration on day 1 to completion of the end of study visit (day 9)

Study Arms (5)

Mild hepatic impairment: Etavopivat dose 2

EXPERIMENTAL

Participants will receive a single dose of oral etavopivat.

Drug: Etavopivat

Moderate hepatic impairment: Etavopivat dose 2

EXPERIMENTAL

Participants will receive a single dose of oral etavopivat.

Drug: Etavopivat

Healthy matched controls: Etavopivat dose 2

EXPERIMENTAL

Participants will receive a single dose of oral etavopivat.

Drug: Etavopivat

Severe hepatic impairment: Etavopivat dose 1

EXPERIMENTAL

Participants will receive a single dose of oral etavopivat.

Drug: Etavopivat

Healthy matched controls: Etavopivat dose 1

EXPERIMENTAL

Participants will receive a single dose of oral etavopivat.

Drug: Etavopivat

Interventions

Etavopivat DRUG

Participants will receive a single dose of etavopivat orally.

Healthy matched controls: Etavopivat dose 1; Healthy matched controls: Etavopivat dose 2; Mild hepatic impairment: Etavopivat dose 2; Moderate hepatic impairment: Etavopivat dose 2; Severe hepatic impairment: Etavopivat dose 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• \- 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.

You may not qualify if:

• 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.
• \- 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (3)

Orlando Clinical Research Center

Orlando, Florida, 32806, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Amer. Rrsch Corp-TX Liver Inst

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: May 20, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (3)