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

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Cohort 2 Ruzasvir + BEM; Drug: Cohort 1 BEM + Ruzasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT05731843

AT-01B-003

Details and patient eligibility

About

Drug-drug interaction study of Ruzasvir and Bemnifosbuvir

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

BEM vs BEM + Ruzasvir n=16

Experimental group

Treatment:

Drug: Cohort 1 BEM + Ruzasvir

Ruzasvir vs Ruzasvir + BEM n=16

Experimental group

Treatment:

Drug: Cohort 2 Ruzasvir + BEM