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

Primary Purpose

Healthy Volunteer, Renal Impairment

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
AT-527
AT-527
AT-527 and Probenecid
Sponsored by
Atea Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Atea Study SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A-Mild Renal Impairment

Group B-Moderate Renal Impairment

Group C-Severe Renal Impairment (optional)

Group D-End-Stage Renal Disease (optional)

Group E-Matched Healthy Subjects

Arm Description

single dose AT-527

single dose AT-527

single dose AT-527

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) of AT-527 Area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) of AT-527 AUC

Secondary Outcome Measures

Full Information

First Posted
October 26, 2022
Last Updated
July 25, 2023
Sponsor
Atea Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05618314
Brief Title
Study of AT-527 in Subjects With Normal and Impaired Renal Function
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atea Pharmaceuticals, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteer, Renal Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A-Mild Renal Impairment
Arm Type
Experimental
Arm Description
single dose AT-527
Arm Title
Group B-Moderate Renal Impairment
Arm Type
Experimental
Arm Description
single dose AT-527
Arm Title
Group C-Severe Renal Impairment (optional)
Arm Type
Experimental
Arm Description
single dose AT-527
Arm Title
Group D-End-Stage Renal Disease (optional)
Arm Type
Experimental
Arm Description
single dose of AT-527 pre- and post-dialysis
Arm Title
Group E-Matched Healthy Subjects
Arm Type
Experimental
Arm Description
Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19
Intervention Type
Drug
Intervention Name(s)
AT-527
Other Intervention Name(s)
Bemnifosbuvir
Intervention Description
single dose AT-527
Intervention Type
Drug
Intervention Name(s)
AT-527
Other Intervention Name(s)
Bemnifosbuvir
Intervention Description
Single dose of AT-527 pre- and post-dialysis
Intervention Type
Drug
Intervention Name(s)
AT-527 and Probenecid
Other Intervention Name(s)
Bemnifosbuvir
Intervention Description
Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax)
Time Frame
Day 1
Title
Pharmacokinetics (PK) of AT-527 Area under the plasma concentration-time curve (AUC)
Time Frame
Day 1
Title
Pharmacokinetics (PK) of AT-527 AUC
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atea Study Clinical Trials Administrator
Phone
8884811607
Email
AteaClinicalTrials@ateapharma.com
Facility Information:
Facility Name
Atea Study Site
City
Québec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atea Study Site
Phone
8884811607
Email
ateaclinicaltrials@ateapharma.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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