Assessing the effects of a drug combination in patients with kidney or liver impairment

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

This study is testing how a combination of two drugs works in people with severe kidney or liver problems compared to healthy volunteers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Atea Pharmaceuticals, Inc. (Industry-sponsored)
• Locations: 2 sites (Orlando, Florida and 1 other locations)
• Trial ID: NCT06911320 on ClinicalTrials.gov

What this trial studies

This study evaluates how severe renal or hepatic impairment affects the pharmacokinetics of a fixed-dose combination of Bemnifosbuvir and Ruzasvir after a single dose. It includes healthy volunteers as well as individuals with severe kidney or liver impairment. Participants will be monitored to ensure stability and compliance with study requirements. The study aims to gather data that could inform future treatments for patients with compromised organ function.

Who should consider this trial

Good fit: Ideal candidates include individuals with severe renal impairment, severe hepatic impairment, or those with normal organ function who match specific demographic criteria.

Not a fit: Patients with mild renal or hepatic impairment or those not meeting the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with severe renal or hepatic impairment.

How similar studies have performed: While this approach is focused on specific organ impairments, similar studies have shown promise in understanding drug pharmacokinetics in compromised populations.

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

Where this trial is running

Orlando, Florida and 1 other locations

• Atea Study Site — Orlando, Florida, United States (Recruiting)
• Atea Study Site — Tampa, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Atea Study Clinical Trials Administrator

Conditions Healthy Volunteer Study; Hepatic Impairment; Renal Impairment