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Study of AT-527 in Subjects With Normal and Impaired Renal Function

Sponsor
Atea Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05618314
Collaborator
(none)
36
Enrollment
1
Location
5
Arms
8.4
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study of AT-527 in Subjects with Normal and Impaired Renal Function

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-Label, Parallel-Group, Single-Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of AT-527 in Adult Subjects With Normal and Impaired Renal Function Sub-Study: Effects of Probenecid on the Pharmacokinetics of AT-527 in Healthy Adult Subjects
Actual Study Start Date :
Oct 17, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A-Mild Renal Impairment

single dose AT-527

Drug: AT-527
single dose AT-527
Other Names:
  • Bemnifosbuvir

    		•
    Experimental: Group B-Moderate Renal Impairment

    single dose AT-527

    Drug: AT-527
    single dose AT-527
    Other Names:
  • Bemnifosbuvir

    		•
    Experimental: Group C-Severe Renal Impairment (optional)

    single dose AT-527

    Drug: AT-527
    single dose AT-527
    Other Names:
  • Bemnifosbuvir

    		•
    Experimental: Group D-End-Stage Renal Disease (optional)

    single dose of AT-527 pre- and post-dialysis

    Drug: AT-527
    Single dose of AT-527 pre- and post-dialysis
    Other Names:
  • Bemnifosbuvir

    		•
    Experimental: Group E-Matched Healthy Subjects

    Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19

    Drug: AT-527 and Probenecid
    Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19
    Other Names:
  • Bemnifosbuvir

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax) [Day 1]

    2. Pharmacokinetics (PK) of AT-527 Area under the plasma concentration-time curve (AUC) [Day 1]

    3. Pharmacokinetics (PK) of AT-527 AUC [Day 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 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

    • BMI of 18.5 to 42.0 kg/m2

    • Willing to comply with the study requirements and to provide written informed consent

    Subjects with Normal Renal Function (Group E):

    • Medically healthy, in the opinion of an Investigator

    • Normal renal function with eGFR ≥ 90 mL/min/1.73m2 at Screening

    Renal Impaired Subjects (Groups A, B, and C):

    • Considered stable in the judgement of an Investigator

    • Presence of severe renal impairment (eGFR ≥ 15 and < 30 mL/min/1.73m2), moderate renal impairment (eGFR ≥ 30 and < 60 mL/min/1.73m2) or mild renal impairment (eGFR ≥ 60 and < 90 mL/min/1.73m2) at Screening: renal impairment should have been stable for at least 1 month prior to Screening.

    Subjects with End-Stage Renal Disease -ESRD (Group D)

    • Considered clinically stable in the opinion of the Investigator

    • Presence of ESRD (eGFR <15 mL/min/1.73m2 and being on intermittent hemodialysis) at Screening and have been stable for at least 1 month prior to Screening

    Exclusion Criteria:

    • Pregnant or breastfeeding

    • Infected with 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

    Subjects with Normal Renal Function (Group E):

    • Any clinically significant illness in the opinion of the investigator

    Subjects with Impaired Renal Function (Group A, B, C and D):

    • History of renal transplant

    • Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) > 10%

    • Subjects requiring treatment for renal impairment or other chronic disease must be on a stable treatment plan

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Atea Study Site Québec 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:
    NCT05618314
    Other Study ID Numbers:
    • AT-03A-011
    First Posted:
    Nov 16, 2022
    Last Update Posted:
    Nov 21, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Renal Insufficiency
    Probenecid

    Study Results

    No Results Posted as of Nov 21, 2022