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

Phase 1

Completed

• Conditions: Renal Impairment; Healthy Volunteer
• Interventions: Drug: AT-527; Drug: AT-527 and Probenecid

• Registration Number: NCT05618314
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-17
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-08
• Study First Posted: 2022-11-16
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A-Mild Renal Impairment	AT-527	single dose AT-527
Group B-Moderate Renal Impairment	AT-527	single dose AT-527
Group C-Severe Renal Impairment (optional)	AT-527	single dose AT-527
Group D-End-Stage Renal Disease (optional)	AT-527	single dose of AT-527 pre- and post-dialysis
Group E-Matched Healthy Subjects	AT-527 and Probenecid	Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax)	Day 1
Pharmacokinetics (PK) of AT-527 Area under the plasma concentration-time curve (AUC)	Day 1
Pharmacokinetics (PK) of AT-527 AUC	Day 1

Trial Locations

Locations (1)

Atea Study Site; 🇨🇦 Québec, Canada