NCT06356194

Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir

A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Drug-Drug Interaction Potential Between Bemnifosbuvir/Ruzasvir and Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy®) in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Atea Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	Cohort 1: Days 1-7 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. Days 8-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 BIK	A co-administered dose of Bemnifosbuvir (BEM)/Ruzasvir (RZR) as separate formulations and Biktarvy (BIK)
DRUG	Cohort 2: Days 1-10 Biktarvy (BIK). Days 11-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered.	A co-administered dose of Bemnifosbuvir (BEM)/Ruzasvir (RZR) as separate formulations and Biktarvy (BIK)

Timeline

• Start date: 2024-04-15
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2024-04-10
• Last updated: 2024-07-31

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study