Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)

Study Overview
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Brief Summary
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This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Endpoints of MK0773 in Healthy Older Men

Conditions
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Healthy

Intervention / Treatment
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* Drug: MK0773
* Drug: Comparator: testosterone enanthate
* Drug: Comparator: placebo oral tablet
* Drug: Comparator: placebo injection


Participation Criteria
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Eligibility Criteria
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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 Criteria: Subject has significant drug allergies Subject has donated blood within the last 8 weeks or has taken an investigational drug in another clinical trial within the last 4 weeks Subject is a regular user or past abuser of any illicit drug (including alcohol) Subject drinks excessive amounts of caffeinated beverages Subject has a history of cancer Subject has a history of prostate or testicular surgery

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MK0773 + placebo injection | Drug: MK0773<br>* Three 25mg oral tablets MK0773 bid, for 12 weeks<br>Drug: Comparator: placebo injection<br>* placebo intramuscular injection q14d, for 12 weeks<br>|
| Active Comparator: 2<br>placebo to MK0773 + testosterone injection | Drug: Comparator: testosterone enanthate<br>* intramuscular injection 200mg testosterone enanthate q14d, for 12 weeks<br>* Other names: Delatestryl;Drug: Comparator: placebo oral tablet<br>* placebo oral tablet bid, for 12 weeks<br>|
| Placebo Comparator: 3<br>placebo to MK0773 + placebo injection | Drug: Comparator: placebo oral tablet<br>* placebo oral tablet bid, for 12 weeks<br>Drug: Comparator: placebo injection<br>* placebo intramuscular injection q14d, for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Adults