Clinical trial NCT05618314: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Renal Impairment
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax)
timeFrame: Day 1
measure: Pharmacokinetics (PK) of AT-527 Area under the plasma concentration-time curve (AUC)
timeFrame: Day 1
measure: Pharmacokinetics (PK) of AT-527 AUC
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Atea Study Site
Study officials:
References: