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ABT-263

Phase 1

Healthy Female Subjects | Small molecule | Other |Abbott Laboratories|Last Updated: Nov 9, 2010

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01053520Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female SubjectsPHASE1 COMPLETED 12 — — Oct 1, 2009Jan 1, 2010Nov 9, 20101 United States
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Study Endpoints
Primary Endpoints
Assess the oral bioavailability of Formulation B1 and Formulation B2 via pharmacokinetic measurements relative to Formulation A .
Each formulation assessed via 13 PK timepoints over 4 days
Secondary Endpoints
Secondary outcome measures include adverse event monitoring, vital signs, physical examinations, ECGs, and laboratory assessments including pharmacogenetics.
Assessed over the confinement period of 17 days of study duration
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Sequence IEXPERIMENTAL -
Sequence IIEXPERIMENTAL -
Sequence IIIEXPERIMENTAL -
Interventions
NameTypeDescription
ABT-263DRUGPeriod 1: Single (oral) dose of 25 mg of Formulation A Period 2: Single (oral) dose of 25 mg of Formulation B1 Period 3: Single (oral) dose of 25 mg of Formulation B2
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Eligibility Criteria
Age Range18 Years — 55 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Female and age is between 18 and 55 years, inclusive. * Must be surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), postmenopausal (for at least 2 years), or practicing at least one acceptable method of birth control. * Must have negative res...

Countries:United States
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