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LY2979165

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Aug 2, 2013

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 Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01524237A Study of LY2979165 and LY2140023 in Healthy VolunteersPHASE1 COMPLETED 52Apr 1, 2012Jul 1, 2013Aug 2, 20132 United Kingdom
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Study Endpoints
Primary Endpoints
Part A: Number of participants with one or more drug related adverse events (AEs) or any serious AEs
Part A: Day 1 through 3
Part B: Changes in hemoglobin oxygenation in the brain during ketamine infusion
Part B: Day 1
Secondary Endpoints
Pharmacokinetics: Area under the concentration curve (AUC) of LY2979165, LY2140023, and active metabolites
Up to Day 3
Pharmacokinetics: Maximum concentration (Cmax) of LY2979165, LY2140023, and active metabolites
Up to Day 3
Pharmacokinetics: Area under the concentration curve (AUC) of ketamine and nor-ketamine
Up to Day 3
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
10 mg LY2140023 + ketamineEXPERIMENTALSingle oral dose of 10 mg LY2140023 followed by intravenous (IV) ketamine during one of the crossover periods
20 mg LY2979165 + ketamineEXPERIMENTALSingle oral dose of 20 mg LY2979165 followed by IV ketamine during one of the crossover periods
40 mg LY2140023 + ketamineEXPERIMENTALSingle oral dose of 40 mg LY2140023 followed by IV ketamine during one of the crossover periods
60 mg LY2979165 + ketamineEXPERIMENTALSingle oral dose of 60 mg LY2979165 followed by IV ketamine during one of the crossover periods
160 mg LY2140023 + ketamineEXPERIMENTALSingle oral dose of 160 mg of LY2140023 followed by IV ketamine during one of the crossover periods
Placebo capsules + ketaminePLACEBO_COMPARATORSingle oral dose of placebo capsules followed by IV ketamine during one of the crossover periods
Placebo tablets + ketaminePLACEBO_COMPARATORSingle oral dose of placebo tablets followed by IV ketamine during one of the crossover periods
Interventions
NameTypeDescription
LY2979165DRUGCapsules administered orally
LY2140023DRUGTablets administered orally
PlaceboOTHERAdministered orally
KetamineOTHERAdministered intravenously (IV)
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Eligibility Criteria
Age Range21 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * are overtly healthy, right-handed, Caucasian (non-Hispanic White by self report) males, as determined by medical history and physical examination * agree to use an effective method of birth control during the study and for a period of 3 months after the final dose of study dru...

Countries:United Kingdom
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