Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir

September 11, 2024 updated by: Atea Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

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

  • United States
    • California
      • Cypress, California, United States, 90630
        • 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
  • Older 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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FDC Fasting
Day 1, Day 7, Day 13
Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions
A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)
Experimental: FDC Fed
Day 1, Day 7, Day 13
Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions
A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)
Experimental: Reference Fasting
Day 1, Day 7, Day 13
Drug: Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions
Bemnifosbuvir (BEM) and Ruzasvir (RZR) as separate formulations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) of FDC compared to reference:(Cmax)
Time Frame: Day 1, Day 7, Day 13
Maximum plasma concentration (Cmax)
Day 1, Day 7, Day 13
Pharmacokinetics (PK) of FDC compared to reference:(AUC)
Time Frame: Day 1, Day 7, Day 13
Area under the plasma concentration-time curve (AUC)
Day 1, Day 7, Day 13
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(Cmax)
Time Frame: Day 1, Day 7, Day 13
Maximum plasma concentration (Cmax)
Day 1, Day 7, Day 13
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)
Day 1, Day 7, Day 13

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)

December 14, 2023

Primary Completion (Actual)

August 25, 2024

Study Completion (Actual)

August 25, 2024

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-01B-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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