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ABT-102

Phase 1

Healthy Volunteers | Small molecule | Other |Abbott Laboratories|Last Updated: Nov 2, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00854659A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy SubjectsPHASE1 COMPLETED 36 — — Mar 1, 2009 -Nov 2, 20101 United States
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Study Endpoints
Primary Endpoints
To determine the safety and tolerability of ABT-102 vs placebo in healthy adults.
10 days
To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults.
10 days
Secondary Endpoints
Exploratory analyses of Quantitive Thermosensory Testing (Warm Detection Threshold, Cold Detection Threshold, Warm Pain Threshold) done at peripheral and oral sites, will be done for ABT-102 and placebo treated subjects.
10 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORABT-102 Tablets, 4 mg BID
2ACTIVE_COMPARATORABT-102 Tablets BID, escalating dose
3ACTIVE_COMPARATORABT-102 Tablets BID, escalating dose
4PLACEBO_COMPARATORPlacebo Tablets, BID
Interventions
NameTypeDescription
ABT-102DRUGBID tablets, 7 days of treatment
PlaceboDRUGBID tablets, 7 days of treatment
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males and Females with a condition of general good health. * Must be willing to participate in all study-related procedures. Exclusion Criteria: * History of significant sensitivity to any drug. * Allergy to soy lecithin, soybeans, soybean oil, or other soybean derivatives. ...

Countries:United States
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