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Clinical Trials/NCT06911320
NCT06911320CompletedPhase 1

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of Bemnifosbuvir and Ruzasvir Administered as a Fixed-Dose Combination in Adult Participants With Severe Renal or Hepatic Impairment in Comparison to Healthy Participants

Atea Pharmaceuticals, Inc.2 sites in 1 country28 target enrollmentStarted: April 9, 2025Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
28
Locations
2
Primary Endpoint
Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
  • •Females must have a negative pregnancy test at Screening and prior to dosing
  • •BMI of 18.5 to 43.0 kg/m2
  • •Willing to comply with the study requirements and to provide written informed consent
  • •Renal Impaired Subjects (Group 1):
  • •Considered stable in the judgement of an Investigator
  • •Presence of severe renal impairment or kidney failure (as defined by eGFR< 30 mL/ min)
  • •Hepatic Impaired Subjects (Group 2):
  • •Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
  • •Presence of severe hepatic impairment (Child-Pugh Class C: score of 10 to 15).
  • •Subjects with Normal Hepatic and Renal Function (Group 3):
  • •Medically healthy, in the opinion of an Investigator
  • •Must match by gender, age (± 10 years), and BMI (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment

Exclusion Criteria

  • •Pregnant or breastfeeding
  • •Infected with hepatitis B virus, hepatitis C virus or HIV
  • •Abuse of alcohol or drugs
  • •Use of other investigational drugs within 28 days of dosing
  • •Other clinically significant medical conditions or laboratory abnormalities
  • •Renal and Hepatic Impaired Subjects (Group 1 and 2):
  • •Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c > 10%
  • •Undergoing any method of dialysis
  • •Subjects requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan
  • •Renal Impaired Subjects (Group 1):
  • •History of renal transplant
  • •Concurrent use of medications known to affect the elimination of serum creatinine
  • •Hepatic Impaired Subjects (Group 2):
  • •History of liver transplant
  • •Evidence of hepatic carcinoma presence at Screening

Arms & Interventions

Group 1 - Severe Renal Impairment

Experimental

Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Intervention: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination (Drug)

Group 2 - Severe Hepatic Impairment

Experimental

Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Intervention: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination (Drug)

Group 3 - Matched Healthy Subjects

Experimental

Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Intervention: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination (Drug)

Outcomes

Primary Outcomes

Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC)

Time Frame: Day 1

Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax)

Time Frame: Day 1

Pharmacokinetics (PK) of BEM/RZR AUC

Time Frame: Day 1

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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