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OpenTrials
Completed

NCT Number: NCT06204679

Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir

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

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Cypress, California, 90630, United States

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

Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions

Drug

A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)

Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions

Drug

A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)

Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions

Drug

Bemnifosbuvir (BEM) and Ruzasvir (RZR) as separate formulations

Primary outcomes

  1. Pharmacokinetics (PK) of FDC compared to reference:(Cmax)

    Time frame: Day 1, Day 7, Day 13

    Maximum plasma concentration (Cmax)

  2. Pharmacokinetics (PK) of FDC compared to reference:(AUC)

    Time frame: Day 1, Day 7, Day 13

    Area under the plasma concentration-time curve (AUC)

  3. Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(Cmax)

    Time frame: Day 1, Day 7, Day 13

    Maximum plasma concentration (Cmax)

  4. Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(AUC)

    Time frame: Day 1, Day 7, Day 13

    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 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2024
Registry last updated
Sep 19, 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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