Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions; Drug: Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions; Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions

Study type: Interventional

Funder types: Industry

Identifiers

NCT06204679

AT-01B-005

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 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 18-30 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

FDC Fasting

Experimental group

Description:

Day 1, Day 7, Day 13

Treatment:

Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions

FDC Fed

Experimental group

Description:

Day 1, Day 7, Day 13

Treatment:

Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions

Reference Fasting

Experimental group

Description:

Day 1, Day 7, Day 13

Treatment:

Drug: Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions