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Completed

NCT Number: NCT06356194

Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir

Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Québec, Montreal, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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.

Drug

A co-administered dose of Bemnifosbuvir (BEM)/Ruzasvir (RZR) as separate formulations and Biktarvy (BIK)

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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