Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir

A Phase 1, Open-Label Study to Assess Comparative Bioavailability and Effect of Food on a Prototype Fixed-Dose Combination of Bemnifosbuvir and Ruzasvir Versus Individual Dosage Forms Taken Concomitantly in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06204679

Enrollment

Registered

2024-01-12

Start date

2023-12-14

Completion date

2024-08-25

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer Study

Brief summary

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

Interventions

DRUGBemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions

A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)

DRUGBemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions

A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)

DRUGBemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions

Bemnifosbuvir (BEM) and Ruzasvir (RZR) as separate formulations

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics (PK) of FDC compared to reference:(Cmax)	Day 1, Day 7, Day 13	Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) of FDC compared to reference:(AUC)	Day 1, Day 7, Day 13	Area under the plasma concentration-time curve (AUC)
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(Cmax)	Day 1, Day 7, Day 13	Maximum plasma concentration (Cmax)
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(AUC)	Day 1, Day 7, Day 13	Area under the plasma concentration-time curve (AUC)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026