Study of Bemnifosbuvir on Cardiac Repolarization in Healthy Subjects

Phase 1CompletedNCT05905484

Atea Pharmaceuticals, Inc.35 enrolled

Overview

This study will assess the effects of Bemnifosbuvir on cardiac repolarization in healthy Adult Subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteer Study

Interventions

Bemnifosbuvir (BEM)DRUG

A single dose of BEM will be administered.

PlaceboDRUG

A single dose of matching placebo will be administered.

MoxifloxacinDRUG

A single dose of Moxifloxacin will be administered.

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 * Females must have a negative pregnancy test at Screening and prior to dosing * 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: * Pregnant or breastfeeding * Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19 * Abuse of alcohol or drugs * Use of other investigational drugs within 28 days of dosing * Other clinically significant medical conditions or laboratory abnormalities

Locations (1)

Atea Study Site

Québec, Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc).

C-QTc analysis

Time frame: 24 hours prior to dosing thru 48 hours post dose

Data from ClinicalTrials.gov

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