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NCT06204679 Clinical Trial

Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir

Healthy Volunteer Study Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06204679
Other study ID # AT-01B-005
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 14, 2023
Est. completion date February 12, 2024

Study information
Verified date January 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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date February 12, 2024
Est. primary completion date February 12, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 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:
• Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions
A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)
• Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions
A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)
• Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions
Bemnifosbuvir (BEM) and Ruzasvir (RZR) as separate formulations

Locations
Country Name City State
United States Atea Study Site Cypress California

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

Country where clinical trial is conducted

United States, 

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