Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir

Phase 1

Recruiting

• Conditions: Healthy Volunteer Study
• Interventions: Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions; Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions; Drug: Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions

• Registration Number: NCT06204679
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

This study will assess comparative bioavailability and effect of food on a prototype fixed-dose combination (FDC) of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in healthy subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-14
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-11
• Study First Posted: 2024-01-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-08-13
• Study Completion: 2024-08-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.
• Minimum body weight of 50 kg and body mass index (BMI) of 18-30 kg/m2.
• Willing to comply with the study requirements and to provide written informed consent.

Exclusion Criteria

• Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.
• Abuse of alcohol or drugs.
• Use of other investigational drugs within 28 days of dosing.
• Concomitant use of prescription medications, or systemic over-the-counter medications.
• Other clinically significant medical conditions or laboratory abnormalities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FDC Fed	Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions	Day 1, Day 7, Day 13
FDC Fasting	Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions	Day 1, Day 7, Day 13
Reference Fasting	Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions	Day 1, Day 7, Day 13

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of FDC compared to reference:(Cmax)	Day 1, Day 7, Day 13	Maximum plasma concentration (Cmax)
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(AUC)	Day 1, Day 7, Day 13	Area under the plasma concentration-time curve (AUC)
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(Cmax)	Day 1, Day 7, Day 13	Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) of FDC compared to reference:(AUC)	Day 1, Day 7, Day 13	Area under the plasma concentration-time curve (AUC)

Trial Locations

Locations (1)

Atea Study Site; 🇺🇸 Cypress, California, United States