NCT06204679

Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir

A Phase 1, Open-Label Study to Assess Comparative Bioavailability and Effect of Food on a Prototype Fixed-Dose Combination of Bemnifosbuvir and Ruzasvir Versus Individual Dosage Forms Taken Concomitantly in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Atea Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions	A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)
DRUG	Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions	A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)
DRUG	Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions	Bemnifosbuvir (BEM) and Ruzasvir (RZR) as separate formulations

Timeline

• Start date: 2023-12-14
• Primary completion: 2024-08-25
• Completion: 2024-08-25
• First posted: 2024-01-12
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study