Etavopivat for Liver Disease

Phase 1

Recruiting

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from imp administration on day 1 to completion of the end of study visit (day 9)

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at a new drug called etavopivat in people with liver problems and people with normal liver function for comparison. Everyone will take a single dose of the drug by mouth with

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions typical of new oral drugs such as digestive discomfort, allergic reactions, or changes in blood tests that monitor liver function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from imp administration on day 1 to completion of the end of study visit (day 9)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from imp administration on day 1 to completion of the end of study visit (day 9)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from imp administration on day 1 to completion of the end of study visit (day 9) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

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

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

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