Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir

Phase 1CompletedNCT05731843

Atea Pharmaceuticals, Inc.32 enrolled

Overview

Drug-drug interaction study of Ruzasvir and Bemnifosbuvir

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer Study

Interventions

Cohort 1 BEM + RuzasvirDRUG

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

Cohort 2 Ruzasvir + BEMDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Atea Study Site

Québec, Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Pharmacokinetics (PK) of BEM

Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)

Time frame: Days 6, 12, 18

Pharmacokinetics (PK) of Ruzasvir

Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)

Time frame: Days 6, 12, 18

Data from ClinicalTrials.gov

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