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Healthy matched controls: Etavopivat dose 2 for Liver Disease

Phase 1
Waitlist Available
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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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)
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Severe hepatic impairment: Etavopivat dose 1Experimental Treatment1 Intervention
Participants will receive a single dose of oral etavopivat.
Group II: Moderate hepatic impairment: Etavopivat dose 2Experimental Treatment1 Intervention
Participants will receive a single dose of oral etavopivat.
Group III: Mild hepatic impairment: Etavopivat dose 2Experimental Treatment1 Intervention
Participants will receive a single dose of oral etavopivat.
Group IV: Healthy matched controls: Etavopivat dose 2Experimental Treatment1 Intervention
Participants will receive a single dose of oral etavopivat.
Group V: Healthy matched controls: Etavopivat dose 1Experimental Treatment1 Intervention
Participants will receive a single dose of oral etavopivat.

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,515 Previous Clinical Trials
2,415,311 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
107 Previous Clinical Trials
140,069 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for participants in this research study?

"According to details on clinicaltrials.gov, recruitment for this trial has concluded. The study was initially listed on 3/29/2024 and last updated on 3/22/2024. While participation is no longer open for this particular trial, there are presently 279 other active trials seeking candidates."

Answered by AI

What level of risk does mild liver damage pose for individuals taking Etavopivat dose 2?

"Our evaluation at Power places the safety rating of Mild hepatic impairment: Etavopivat dose 2 at a level 1. This is due to its Phase 1 trial status, signifying scarce evidence backing both safety and effectiveness."

Answered by AI

What are the main goals being pursued in this research endeavor?

"Throughout the trial period from the initial administration of the investigational medicinal product on day 1 until the final end-of-study visit (day 9), the primary aim is to determine the peak observed level of etavopivat in plasma after a single dose (Cmax, etavopivat). Secondary objectives encompass evaluating factors such as half-life post-dose for etavopivat (t1/2, etavopivat) measured in hours, total exposure represented by area under the concentration-time curve up to last quantifiable measurement following one dose (AUC0-last, etavopivat)"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Research Study on Etavopivat in Participants With and Without Liver Disease
2024. "A Research Study on Etavopivat in Participants With and Without Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06336018.
All > Liver Disease
~32 spots leftby Jul 2025
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