RECRUITING

Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function

Conditions

Healthy Volunteer Study Hepatic Impairment Renal Impairment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-04-09

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06911320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * Considered stable in the judgement of an Investigator * Presence of severe renal impairment or kidney failure (as defined by eGFR\< 30 mL/ min) * 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). * 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	* 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 * 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 * History of renal transplant * Concurrent use of medications known to affect the elimination of serum creatinine * History of liver transplant * Evidence of hepatic carcinoma presence at Screening

Inclusion Criteria

Exclusion 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
* Considered stable in the judgement of an Investigator
* Presence of severe renal impairment or kidney failure (as defined by eGFR\< 30 mL/ min)
* 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).
* 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

* 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
* 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
* History of renal transplant
* Concurrent use of medications known to affect the elimination of serum creatinine
* History of liver transplant
* Evidence of hepatic carcinoma presence at Screening

Contacts and Locations

Study Contact

Atea Study Clinical Trials Administrator

CONTACT

888-481-1607

ateaclinicaltrials@ateapharma.com

Study Locations (Sites)

Atea Study Site

Orlando, Florida, 32809

United States

Atea Study Site

Tampa, Florida, 33603

United States

Collaborators and Investigators

Sponsor: Atea Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-09

Study Completion Date2025-08

Study Record Updates

Study Start Date2025-04-09

Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

Healthy Volunteer Study
Hepatic Impairment
Renal Impairment