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NCT06356194 Clinical Trial

Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir

Healthy Volunteer Study Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06356194
Other study ID # AT-01B-006
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date April 15, 2024
Est. completion date May 30, 2024

Study information
Verified date April 2024
Source Atea Pharmaceuticals, Inc.
Contact Atea Study Clinical Trials Administrator
Phone 888-481-1607
Email ateaclinicaltrials@ateapharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 28
Est. completion date May 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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)
• 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)

Locations
Country Name City State
Canada Atea Study Site Québec Montreal

Sponsors (1)
Lead Sponsor Collaborator
Atea Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR). Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC) Day 2, Days 4-7, Days 14-17, Days 21-24
Primary To determine the effect of Bemnifosbuvir (BEM)/Ruzasvir (RZR) combination on the PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC) Days 7-10, Day 12, Days 14-17, Days 21-24.
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