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Samidorphan

Phase 1

Healthy Volunteers | Small molecule | Other |Alkermes plc|Last Updated: Dec 2, 2014

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 Enrollment59
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02218021A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid UsersPHASE1 COMPLETED 59 — — Aug 1, 2014Nov 1, 2014Dec 2, 20141 United States
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Study Endpoints
Primary Endpoints
Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)
Approximately 4 weeks
Secondary Endpoints
Safety: Incidence of adverse events (AEs)
Approximately 5.5 weeks
Pharmacokinetics: Plasma concentrations of samidorphan and metabolite
Approximately 4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Samidorphan Dose 1EXPERIMENTAL -
Samidorphan Dose 2EXPERIMENTAL -
Samidorphan Dose 3EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Oxycodone Dose 1ACTIVE_COMPARATOR -
Oxycodone Dose 2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
SamidorphanDRUG -
PlaceboDRUG -
OxycodoneDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Be in good general physical health * Body mass index of 18-34 kg/m2, inclusive with minimum weight of 50 kg * Recreational opioid use experience for non-therapeutic purposes (at \>/= 10 times in lifetime and \>/= 1 in previous 3 months * Agree to use an approved method of birt...

Countries:United States
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