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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 68
- Primary Endpoint
- Number of subjects with Serious CAEs
Study Overview
Brief Summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
MK0773 + placebo injection
Intervention: MK0773 (Drug)
Outcomes
Primary Outcomes
Number of subjects with Serious CAEs
Time Frame: 12 weeks
Number of subjects with drug-related CAEs
Time Frame: 12 weeks
Number of subjects with serious drug-related CAEs
Time Frame: 12 weeks
Number of subjects with serious LAEs
Time Frame: 12 weeks
Number of subjects with serious drug-related LAEs
Time Frame: 12 weeks
Number of subjects that discontinued with LAEs
Time Frame: 12 weeks
Number of subjects with Clinical Adverse Events (CAE)
Time Frame: 12 weeks
Number of subjects that discontinued with CAEs
Time Frame: 12 weeks
Number of subjects with Laboratory Adverse Events (LAE)
Time Frame: 12 weeks
Number of subjects with drug-related LAEs
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported