Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)
- Registration Number
- NCT01017458
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 68
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 MK0773 MK0773 + placebo injection
- Primary Outcome Measures
Name Time Method 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 with serious LAEs 12 weeks Number of subjects with serious drug-related LAEs 12 weeks Number of subjects that discontinued with LAEs 12 weeks Number of subjects with Clinical Adverse Events (CAE) 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
- Secondary Outcome Measures
Name Time Method