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Baclofen IR

Phase 1

Alcohol Dependence | Small molecule | Other |Alkermes plc|Last Updated: Aug 23, 2011

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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00802035ALK29-002: A Study of Baclofen Formulations in Healthy AdultsPHASE1 COMPLETED 16 — — Nov 1, 2008Feb 1, 2009Aug 23, 20111 United States
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Study Endpoints
Primary Endpoints
Maximum plasma concentration (Cmax)
5 weeks
Secondary Endpoints
Time to Cmax
5 weeks
Significant abnormal laboratory findings
5 weeks
Area under the plasma concentration curve (AUC)
5 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IR amACTIVE_COMPARATOR30 mg, single dose, morning administration (immediate release \[IR\])
ER amEXPERIMENTAL30 mg; single dose; morning administration (extended release \[ER\])
ER pmEXPERIMENTAL30 mg; single dose; evening administration
IR pmACTIVE_COMPARATOR30 mg; single dose; evening administration
Interventions
NameTypeDescription
Baclofen IRDRUG30 mg; single dose
Baclofen ERDRUG30 mg; single dose
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Between the ages of 18 and 65 years * Body mass index of 19 to 30 kg/m2 at screening * If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception for the duration of the study Exclusion Criteria: * Pregnancy and/or current...

Countries:United States
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