COMPLETED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-05-20

Study Completion:2025-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06336018

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Clinical Transparency (dept. 2834)

STUDY_DIRECTOR

Novo Nordisk A/S

Study Locations (Sites)

Orlando Clinical Research Center

Orlando, Florida, 32806

United States

Orlando Clinical Research Center

Orlando, Florida, 32809

United States

Amer. Rrsch Corp-TX Liver Inst

San Antonio, Texas, 78215

United States

Collaborators and Investigators

Sponsor: Novo Nordisk A/S

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-20

Study Completion Date2025-08-01

Study Record Updates

Study Start Date2024-05-20

Study Completion Date2025-08-01

Terms related to this study

Additional Relevant MeSH Terms

Liver Diseases