Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir

Healthy Volunteer Study Clinical Trial

— AT-527  

Official title:

A Phase 1, Open-Label Study to Evaluate the Potential Drug-Drug Interaction Between Bemnifosbuvir and Ruzasvir and Food-Drug Interaction in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05731843
• Other study ID #: AT-01B-003
• Status: Completed
• Phase: Phase 1
• Start date: January 30, 2023
• Est. completion date: March 15, 2023

Study information

• Verified date: May 2023
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Drug-drug interaction study of Ruzasvir and Bemnifosbuvir

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• Cohort 1 BEM + Ruzasvir
Days 1 to 6 BEM under fasting conditions. Days 7 to 12 of BEM and Ruzasvir coadministered under fasting conditions. Days 13 to 18 of BEM and Ruzasvir coadministered under fed conditions
• Cohort 2 Ruzasvir + BEM
Days 1 to 6 of Ruzasvir under fasting conditions. Days 7 to 12 of Ruzasvir and BEM coadministered under fasting conditions. Days 13 to 18 of Ruzasvir and BEM coadministered under fed conditions

Locations

Country	Name	City	State
Canada	Atea Study Site	Québec	Montreal, Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) of BEM	Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)	Days 6, 12, 18
Primary	Pharmacokinetics (PK) of Ruzasvir	Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)	Days 6, 12, 18