Bemnifosbuvir/Ruzasvir for Liver Disease and Kidney Failure
Recruiting at 1 trial location
AS
Overseen ByAtea Study Clinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Atea Pharmaceuticals, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
Eligibility Criteria
This study is for people with severe liver or kidney problems, as well as healthy individuals. Participants will receive a single dose of a combined medication called Bemnifosbuvir/Ruzasvir to see how their bodies handle the drug.Inclusion Criteria
Willing to comply with the study requirements and to provide written informed consent
Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
I have taken a pregnancy test and it was negative.
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Exclusion Criteria
Pregnant or breastfeeding
Use of other investigational drugs within 28 days of dosing
Abuse of alcohol or drugs
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single dose of Bemnifosbuvir/Ruzasvir as a fixed-dose combination
Single dose
Follow-up
Participants are monitored for safety and pharmacokinetics after the single dose
4 weeks
Treatment Details
Interventions
- Bemnifosbuvir/Ruzasvir
Trial Overview The trial is testing how a fixed-dose combination of two drugs, Bemnifosbuvir and Ruzasvir, behaves in the body after one dose in people with normal health or those with severe liver or kidney issues.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Group 3 - Matched Healthy SubjectsExperimental Treatment1 Intervention
Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
Group II: Group 2 - Severe Hepatic ImpairmentExperimental Treatment1 Intervention
Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
Group III: Group 1 - Severe Renal ImpairmentExperimental Treatment1 Intervention
Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
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Who Is Running the Clinical Trial?
Atea Pharmaceuticals, Inc.
Lead Sponsor
Trials
29
Recruited
4,600+
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