Study of Bemnifosbuvir on Cardiac Repolarization in Healthy Subjects

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Bemnifosbuvir (BEM); Drug: Moxifloxacin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05905484

AT-03A-008

Details and patient eligibility

About

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

Enrollment: 35 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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35 participants in 4 patient groups, including a placebo group

Bemnifosbuvir (BEM) therapeutic dose

Experimental group

Description:

oral tablets

Treatment:

Drug: Bemnifosbuvir (BEM)

Bemnifosbuvir (BEM) supratherapeutic dose

Experimental group

Description:

oral tablets

Treatment:

Drug: Bemnifosbuvir (BEM)

Placebo

Placebo Comparator group

Description:

oral tablets

Treatment:

Drug: Placebo

Moxifloxacin

Active Comparator group

Description:

oral tablet

Treatment:

Drug: Moxifloxacin