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Comparator: low dose testosterone

Phase 1

Muscle Anabolism | Small molecule | Other |Merck & Company, Inc.|Last Updated: Jan 30, 2015

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00812396Biomarkers of Muscle Anabolism (MK-0000-082)PHASE1 COMPLETED 30Nov 1, 2007Feb 1, 2008Jan 30, 2015 -
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Study Endpoints
Primary Endpoints
comparative proteomics on proteins present in the vastus lateralis or plasma
1 week
Secondary Endpoints
mRNA or miRNA expression in the vastus lateralis or in peripheral blood
1 week
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORLow dose testosterone
2ACTIVE_COMPARATORHigh dose testosterone
3PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
Comparator: low dose testosteroneDRUGSubjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 200 mg (0.8 mL) testosterone.
Comparator: high dose testosteroneDRUGSubjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 600 mg (2.4 mL) testosterone.
Comparator: placeboDRUGSubjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 0.8 mL placebo saline solution.
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Eligibility Criteria
Age Range18 Years — 40 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * subject is a healthy male between 18 and 40 years old * subject's weight is stable over the past 3 months * subject agrees to refrain from consuming alcohol during study * subject agrees to consume no caffeine while in the CRU * subject agrees to follow meat-free diet * subjec...

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