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AT-527: Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir

Sponsor
Atea Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05731843
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
30
Anticipated Duration (Days)
32.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Drug-drug interaction study of Ruzasvir and Bemnifosbuvir

Condition or Disease Intervention/Treatment Phase
  • Drug: Cohort 1 BEM + Ruzasvir
  • Drug: Cohort 2 Ruzasvir + BEM
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: BEM vs BEM + Ruzasvir n=16

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
Other Names:
  • AT-527

    		•
    Experimental: Ruzasvir vs Ruzasvir + BEM n=16

    Drug: 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
    Other Names:
  • AT-527

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK) of BEM [Days 6, 12, 18]

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

    2. Pharmacokinetics (PK) of Ruzasvir [Days 6, 12, 18]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 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.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Atea Study Site Québec Montreal, Quebec Canada

    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:
    NCT05731843
    Other Study ID Numbers:
    • AT-01B-003
    First Posted:
    Feb 16, 2023
    Last Update Posted:
    Feb 16, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Ruzasvir

    Study Results

    No Results Posted as of Feb 16, 2023