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Completed

NCT Number: NCT05731843

Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir

Drug-drug interaction study of Ruzasvir and Bemnifosbuvir

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Québec, Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cohort 1 BEM + Ruzasvir

Drug

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

Other names: AT-527

Cohort 2 Ruzasvir + BEM

Drug

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

Other names: AT-527

Primary outcomes

  1. Pharmacokinetics (PK) of BEM

    Time frame: Days 6, 12, 18

    Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)

  2. Pharmacokinetics (PK) of Ruzasvir

    Time frame: Days 6, 12, 18

    Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: AT-527

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2023
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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