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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment29
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05137626Drug-drug Interaction Study of Digoxin and AT-527 (R07496998)PHASE1 COMPLETED 29 — — Nov 3, 2021Dec 12, 2021Feb 28, 20221 Canada
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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 — 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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