Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir

July 29, 2024 updated by: Atea Pharmaceuticals, Inc.

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

Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Montreal
      • Québec, Montreal, Canada
        • Atea Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BEM/RZR vs BEM/RZR + BIK vs BIK
n=14
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)
Experimental: BIK vs BEM/RZR + BIK vs BEM/RZR
n=14
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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atea Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-01B-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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