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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618314
• Other study ID #: AT-03A-011
• Status: Recruiting
• Phase: Phase 1
• Start date: October 17, 2022
• Est. completion date: April 23, 2024

Study information

• Verified date: July 2023
• Source: Atea Pharmaceuticals, Inc.
• Contact: Atea Study Clinical Trials Administrator
• Phone: 8884811607
• Email: AteaClinicalTrials[@]ateapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 23, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• AT-527
single dose AT-527
• AT-527
Single dose of AT-527 pre- and post-dialysis
• AT-527 and Probenecid
Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19

Locations

Country	Name	City	State
Canada	Atea Study Site	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax)		Day 1
Primary	Pharmacokinetics (PK) of AT-527 Area under the plasma concentration-time curve (AUC)		Day 1
Primary	Pharmacokinetics (PK) of AT-527 AUC		Day 1