Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Digoxin and Rosuvastatin

Phase 1CompletedNCT06921941

Atea Pharmaceuticals, Inc.38 enrolled

Overview

Drug-drug interaction study between Bemnifosbuvir/Ruzasvir and Digoxin or Rosuvastatin

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer Study

Interventions

Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZRDRUG

Treatment-A (Digoxin): A single dose of digoxin will be administered under fasting conditions. Treatment-B (Digoxin + BEM/RZR): A single dose of digoxin will be co-administered a single dose of BEM/RZR under fasting conditions. Treatment-C (Digoxin + 2h BEM/RZR): A single dose of digoxin will be administered under fasting conditions. Then, a single dose of BEM/RZR will be administered approximately 2 hours later under fasting conditions.

Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZRDRUG

Treatment-D (rosuvastatin): A single dose of rosuvastatin will be administered under fasting conditions. Treatment-E (rosuvastatin + BEM/RZR): A single dose of rosuvastatin will be co-administered with a single dose BEM/RZR under fasting conditions. Treatment-F (rosuvastatin + 2h BEM/RZR): A single dose of rosuvastatin will be administered under fasting conditions. Then, a single dose BEM/RZR will be administered approximately 2 hours later under fasting 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 18-30 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.

Locations (1)

Atea Study Site

Québec, Montreal, Canada

Outcomes

Primary Outcomes

PK of Digoxin and Rosuvastatin (Cmax)

Time frame: Digoxin: Days 1,15, 29; Rosuvastatin: Days 1, 8, 15

PK of Digoxin and Rosuvastatin (AUC)

Time frame: Digoxin: Days 1,15, 29; Rosuvastatin: Days 1, 8, 15

Data from ClinicalTrials.gov

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