Etavopivat for Liver Disease

Recruiting at 1 trial location

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Must not be taking: UGT2B7 inhibitors, CYP3A4 inducers

Disqualifiers: Pregnancy, Diabetes, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Participants with hepatic impairment must be on a stable dose of their current medications for at least 14 days before the study. However, all participants must avoid certain medications that affect liver enzymes for a specified period before and during the study.

What is the purpose of this trial?

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.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

This trial is for adults with a BMI of 18.5-42 kg/m^2 and weight over 40 kg, who have stable liver disease (Child-Pugh class A, B or C) or normal liver function. Participants must not be on prohibited medications, have no severe allergies to the drug being tested, and women should not be pregnant or breastfeeding.

Inclusion Criteria

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

I am either male or female.

My weight is at least 40 kg.

Exclusion Criteria

Participant unable to refrain from or anticipates the use of any medications or substances prohibited in the study

Known or suspected hypersensitivity to study intervention or related products

Participation in any interventional clinical study within 30 days or 5 times the half-life of the previous investigational medical product (IMP) before screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of etavopivat

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics, safety, and tolerability after dosing

7-9 days

Daily monitoring (in-person)

Treatment Details

Interventions

• Etavopivat

Trial Overview The study tests etavopivat in people with different levels of liver health. Each participant will take a single oral dose of etavopivat with water. The effects will then be monitored for about a week to see how it works in those with and without liver issues.

Participant Groups

Group I: Severe hepatic impairment: Etavopivat dose 1 Experimental Treatment 1 Intervention

Participants will receive a single dose of oral etavopivat.

Group II: Moderate hepatic impairment: Etavopivat dose 2 Experimental Treatment 1 Intervention

Participants will receive a single dose of oral etavopivat.

Group III: Mild hepatic impairment: Etavopivat dose 2 Experimental Treatment 1 Intervention

Participants will receive a single dose of oral etavopivat.

Group IV: Healthy matched controls: Etavopivat dose 2 Experimental Treatment 1 Intervention

Participants will receive a single dose of oral etavopivat.

Group V: Healthy matched controls: Etavopivat dose 1 Experimental Treatment 1 Intervention

Participants will receive a single dose of oral etavopivat.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen