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RDC-0313 + Buprenorphine

Phase 1

Substance-Related Disorders | Small molecule | Other |Alkermes plc|Last Updated: Jan 11, 2017

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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01046539Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy AdultsPHASE1 COMPLETED 12 — — Jan 1, 2010Jul 1, 2010Jan 11, 20171 United States
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Study Endpoints
Primary Endpoints
Pharmacodynamics (PD) of study drug
24 hour period
VAS Scores
24 Hours period
Pupuillometry Assessments
24 Hour Period
Subjective Symptoms
15 min pre and post nal, 3 hrs post bup admin
Secondary Endpoints
To determine pharmacokinetics (PK) and evaluate safety and tolerability of study drug
24 hour period
Max plasma concentration
24 Hour Period
Time to maximum plasma concentration
24 Hour Period
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RDC-0313 + BuprenorphineACTIVE_COMPARATORCohort 1 (1 and 4 mg) + 8 mg Cohort 2 (dependent on Cohort 1 results)
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
RDC-0313 + BuprenorphineDRUG1 and 4 mg (1 dose for each) + 8 mg
PlaceboDRUG0 mg
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject must be capable of understanding and complying with the protocol and has signed the informed consent * Must be 18-55 years of age * Must have a body mass index of 18.0-30.0 kg/m2 at screening * Female subjects must agree to use an acceptable method of contraception fro...

Countries:United States
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