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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 involving healthy volunteers and patients with these conditions. AT-527 is not approved and remains in clinical development.

Who makes AT-527?

AT-527 is being developed by Atea Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AVIR. The company has conducted multiple clinical trials to evaluate the drug's safety and efficacy.

What phase is AT-527 in?

AT-527 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 trial evaluated the drug in non-hospitalized adult patients with mild or moderate COVID-19. AT-527 is investigational and has not received FDA approval.

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 COVID-19 patients (NCT04709835), a drug-drug interaction study with digoxin (NCT05137626), and a renal impairment study (NCT05618314).

Is AT-527 the same as R07496998?

Yes, AT-527 is also known as R07496998. This alternative name appears in the drug-drug interaction study of digoxin and AT-527, where the compound is referred to as R07496998 in the trial title.