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

NCT05618314 | Completed Phase 1 FDA Drug

• 1 other identifier: AT-03A-011
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer; Renal Impairment

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (5)

Group A-Mild Renal Impairment

EXPERIMENTAL

single dose AT-527

Drug: AT-527

Group B-Moderate Renal Impairment

EXPERIMENTAL

single dose AT-527

Drug: AT-527

Group C-Severe Renal Impairment (optional)

EXPERIMENTAL

single dose AT-527

Drug: AT-527

Group D-End-Stage Renal Disease (optional)

EXPERIMENTAL

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

Drug: AT-527

Group E-Matched Healthy Subjects

EXPERIMENTAL

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

Drug: AT-527 and Probenecid

Interventions

AT-527 DRUG

single dose AT-527

Also known as: Bemnifosbuvir

Group A-Mild Renal Impairment; Group B-Moderate Renal Impairment; Group C-Severe Renal Impairment (optional)

AT-527 and Probenecid DRUG

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

Also known as: Bemnifosbuvir

Group E-Matched Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atea Pharmaceuticals, Inc.: lead

Study Sites (1)

Atea Study Site

Québec, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

AT-511; Probenecid

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 16, 2022
• Study Start: October 17, 2022
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)