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The Study of Bemnifosbuvir in Healthy Japanese Subjects

Sponsor
Atea Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05905497
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
23
Actual Duration (Days)
18.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Bemnifosbuvir (BEM)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Bemnifosbuvir in Healthy Adult Japanese Subjects
Actual Study Start Date :
Apr 26, 2023
Actual Primary Completion Date :
May 19, 2023
Actual Study Completion Date :
May 19, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bemnifosbuvir (BEM)

oral tablet

Drug: Bemnifosbuvir (BEM)
BEM administered BID for 4 days and QD on Day 5 (9 consecutive doses)
Other Names:
  • AT-527

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax) [Day 1, Day 5]

    2. Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC) [Day 1, Day 5]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Atea Study Site Cypress California United States 90630

    Sponsors and Collaborators

    • Atea Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Atea Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT05905497
    Other Study ID Numbers:
    • AT-03A-018
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 15, 2023