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AVL-292

Phase 1

Healthy | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Nov 4, 2019

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01692184Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292PHASE1 COMPLETED 54 — — Aug 1, 2012Oct 8, 2012Nov 4, 20191 United States
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Study Endpoints
Primary Endpoints
Adverse Events
Up to 28 days after last AVL-292 dose

Number of participants with adverse events

PK-(Cmax)
24 hours after the last AVL-292 dose on days 1 and 7

Maximum observed concentration in plasma

PK-(AUC)
24 hours after the last AVL-292 dose days 1 and 7

Area under the plasma concentration-time curve

Secondary Endpoints
Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells
24 hours after the last AVL-292 dose days 1 and 7
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
50 mg of AVL-292 and PlaceboEXPERIMENTAL50 mg AVL-292 (2 x 25 mg AVL-292 capsules and 6 placebo capsules) once daily for 7 days administered orally under fasted condition
100 mg of AVL-292 and PlaceboEXPERIMENTAL100 mg AVL-292 (4 x 25 mg AVL-292 capsules and 4 placebo capsules) once daily for 7 days administered orally under fasted condition
200 mg AVL-292EXPERIMENTAL8 x 25 mg AVL-292 capsules orally once daily for 7 days under fasted condition
350 mg of AVL-292EXPERIMENTAL350 mg AVL-292 (14 x 25 mg AVL-292 capsules) once daily for 7 days administered orally under fasted condition
Placebo - 8 capsulesPLACEBO_COMPARATOR8 placebo capsules once daily for 7 days administered orally under fasted condition
Placebo - 14 capsulesPLACEBO_COMPARATOR14 placebo capsules once daily for 7 days administered orally under fasted condition
Interventions
NameTypeDescription
50 mg AVL-292DRUG -
100 mg AVL-292DRUG -
200 mg AVL-292DRUG -
350 mg AVL-292DRUG -
Placebo capsulesDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female subjects of any ethnic origin between ages of 18 and 65 with a body mass index between 18 and 33 Exclusion Criteria: * Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, card...

Countries:United States
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