Investigating etavopivat in patients with and without liver disease

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

This study is testing a new drug called etavopivat to see how it works in people with liver disease compared to those with healthy livers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 2 sites (Orlando, Florida and 1 other locations)
• Trial ID: NCT06336018 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of an investigational drug called etavopivat in participants with liver disease and those with normal liver function. Participants will receive a single oral dose of etavopivat, and the study will monitor their responses over a period of 7 to 9 days. The aim is to understand how the drug behaves in different hepatic conditions, providing insights into its safety and efficacy. Both groups will be closely monitored to assess any differences in drug metabolism and effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stable hepatic impairment or normal liver function.

Not a fit: Patients with acute liver failure or those not meeting the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with liver diseases.

How similar studies have performed: While this approach is novel in its specific focus on etavopivat, similar studies have shown promise in evaluating new treatments for liver diseases.

Eligibility criteria

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.

Where this trial is running

Orlando, Florida and 1 other locations

• Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
• Amer. Rrsch Corp-TX Liver Inst — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Liver Diseases