Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir (AT-527)

A Phase 1, Open-Label Study to Evaluate the Potential Drug-Drug Interaction Between Bemnifosbuvir and Ruzasvir and Food-Drug Interaction in Healthy Adult Subjects

Drug-drug interaction study of Ruzasvir and Bemnifosbuvir

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer Study
• Intervention / Treatment: Drug: Cohort 1 BEM + Ruzasvir; Drug: Cohort 2 Ruzasvir + BEM

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (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 18-29 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BEM vs BEM + Ruzasvir n=16	Drug: Cohort 1 BEM + Ruzasvir; Days 1 to 6 BEM under fasting conditions. Days 7 to 12 of BEM and Ruzasvir coadministered under fasting conditions. Days 13 to 18 of BEM and Ruzasvir coadministered under fed conditions; Other Names: AT-527
Experimental: Ruzasvir vs Ruzasvir + BEM n=16	Drug: Cohort 2 Ruzasvir + BEM; Days 1 to 6 of Ruzasvir under fasting conditions. Days 7 to 12 of Ruzasvir and BEM coadministered under fasting conditions. Days 13 to 18 of Ruzasvir and BEM coadministered under fed conditions; Other Names: AT-527

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) of BEM	Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)	Days 6, 12, 18
Pharmacokinetics (PK) of Ruzasvir	Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)	Days 6, 12, 18

Collaborators and Investigators

• Sponsor: Atea Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Ruzasvir
• Other Study ID Numbers: AT-01B-003

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