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Completed

NCT Number: NCT05905497

The Study of Bemnifosbuvir in Healthy Japanese Subjects

This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in healthy adult Japanese subjects

Completed

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Cypress, California, 90630, United States

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
  • 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 18-32 kg/m2
  • Willing to comply with the study requirements and to provide written informed consent
  • The subject must have been born in Japan and have both parents and 4 grandparents of Japanese descent
  • The subject must have lived outside of Japan for no more than 10 years

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

Treatment and study plan

Bemnifosbuvir (BEM)

Drug

BEM administered BID for 4 days and QD on Day 5 (9 consecutive doses)

Other names: AT-527

Primary outcomes

  1. Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)

    Time frame: Day 1, Day 5

  2. Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)

    Time frame: Day 1, Day 5

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Bemnifosbuvir in Healthy Adult Japanese Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Jun 15, 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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