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opioid receptor kappa antagonist

Phase 1

Alcohol Dependence | Small molecule | Other |Eli Lilly and Company|Last Updated: May 9, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01232439A Study of Brain Receptor Occupancy in Healthy SubjectsPHASE1 COMPLETED 13 — — Dec 1, 2010Apr 1, 2011May 9, 20111 United States
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Study Endpoints
Primary Endpoints
Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)
Baseline, after single dose of study drug
Secondary Endpoints
Pharmacokinetics, area under the curve (AUC)
Days 1 and 2
Number of participants with clinically significant effects
Baseline to study completion
Pharmacokinetics, concentration maximum (Cmax)
Days 1 and 2
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
opioid receptor kappa antagonistEXPERIMENTAL -
Interventions
NameTypeDescription
opioid receptor kappa antagonistDRUGStarting dose of 2 mg, administered orally, once. The potential dose range for this study is 0.2 mg to 30 mg
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female * Have clinical laboratory tests within normal reference ranges * Have arterial and venous access sufficient to allow blood sampling Exclusion Criteria: * Currently enrolled in, or discontinued within the last 30 days from a clinical trial * History of...

Countries:United States
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