Clinical trial NCT06911320: Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer Study
Hepatic Impairment
Renal Impairment
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax)
timeFrame: Day 1
measure: Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC)
timeFrame: Day 1
measure: Pharmacokinetics (PK) of BEM/RZR AUC
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Atea Study Site
state: Florida
city: Tampa
country: United States
facility: Atea Study Site
state: Florida
Study officials:
References: