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AT-527 + digoxin

Phase 1

Healthy Volunteers Study | Small molecule | Other |Atea Pharmaceuticals, Inc.|Last Updated: Feb 28, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

AT-527 + digoxin · 1 trial · 1 indication

Phase 1 1
NCT05137626Drug-drug Interaction Study of Digoxin and AT-527 (R07496998)Healthy Volunteers Study
COMPLETED29 Analytics
PHASE1COMPLETED
Drug-drug Interaction Study of Digoxin and AT-527 (R07496998)
Healthy Volunteers Study
NCT0513762629
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Study Endpoints

Primary Endpoints

To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin
Day 1, Day 15

Maximum plasma concentration (Cmax)

To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin
Day 1, Day 15

Maximum plasma concentration (Cmax)

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AT-527 + digoxin (simultaneous)EXPERIMENTALn=14
AT-527 + digoxin (staggered)EXPERIMENTALn=14

Interventions

NameTypeDescription
AT-527 + digoxinDRUG* Day 1: A single dose of digoxin will be administered. * Day 15: A single dose of AT-527 and digoxin will be co-administered.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 * Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg...

Countries:Canada
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Frequently asked questions about AT-527 + digoxin

What is AT-527 used for?

AT-527 is an investigational small molecule being studied for the treatment of chronic hepatitis C and COVID-19. It has been evaluated in clinical trials for these infectious disease indications, including in patients with mild or moderate COVID-19 who were not hospitalized.

What does AT-527 target?

AT-527 is a small molecule antiviral agent. It is being developed by Atea Pharmaceuticals for infectious disease indications, including chronic hepatitis C and COVID-19. The specific molecular target of AT-527 has not been disclosed in the available clinical trial information.

Who makes AT-527?

AT-527 is being developed by Atea Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AVIR. The company is focused on infectious disease therapeutics and has conducted multiple clinical trials of AT-527.

What phase is AT-527 in?

AT-527 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved by the FDA. All four completed trials, including a Phase 2 study in COVID-19, have finished, and no active trials are currently listed.

What clinical trials is AT-527 in?

AT-527 has been studied in four completed clinical trials. These include a Phase 1 study in healthy and HCV-infected subjects (NCT03219957), a Phase 2 study in non-hospitalized COVID-19 patients (NCT04709835), a Phase 1 mass balance study in healthy males (NCT05004415), and a Phase 1 study in subjects with normal and impaired renal function (NCT05618314).

Is AT-527 the same as other names?

AT-527 is the primary name used in clinical trial records. No alternative names for this drug have been listed in the available trial information. It is consistently referred to as AT-527 across all completed studies.