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MK0773

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Jul 12, 2016

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_CONTROLLEDDMC
Total Trials1
Total Enrollment68
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01017458Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)PHASE1 COMPLETED 68Jun 1, 2007Aug 1, 2008Jul 12, 2016 -
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Study Endpoints
Primary Endpoints
Number of subjects with Clinical Adverse Events (CAE)
12 weeks
Number of subjects with Serious CAEs
12 weeks
Number of subjects with drug-related CAEs
12 weeks
Number of subjects with serious drug-related CAEs
12 weeks
Number of subjects that discontinued with CAEs
12 weeks
Number of subjects with Laboratory Adverse Events (LAE)
12 weeks
Number of subjects with drug-related LAEs
12 weeks
Number of subjects with serious LAEs
12 weeks
Number of subjects with serious drug-related LAEs
12 weeks
Number of subjects that discontinued with LAEs
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALMK0773 + placebo injection
2ACTIVE_COMPARATORplacebo to MK0773 + testosterone injection
3PLACEBO_COMPARATORplacebo to MK0773 + placebo injection
Interventions
NameTypeDescription
MK0773DRUGThree 25mg oral tablets MK0773 bid, for 12 weeks
Comparator: testosterone enanthateDRUGintramuscular injection 200mg testosterone enanthate q14d, for 12 weeks
Comparator: placebo oral tabletDRUGplacebo oral tablet bid, for 12 weeks
Comparator: placebo injectionDRUGplacebo intramuscular injection q14d, for 12 weeks
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Eligibility Criteria
Age Range50 Years — 75 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject is in good general health * Subject agrees to avoid excess alcohol and strenuous physical activity during the study * Subject who is sexually active with partners of reproductive potential agrees to use two forms of appropriate contraception during the study Exclusion...

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