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

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ClinicalTrials.gov Identifier: NCT01017458
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

November 18, 2009
November 20, 2009
July 12, 2016
June 2007
August 2008   (Final data collection date for primary outcome measure)
  • Number of subjects with Clinical Adverse Events (CAE) [ Time Frame: 12 weeks ]
  • 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 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 ]
  • 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 ]
Same as current
Complete list of historical versions of study NCT01017458 on ClinicalTrials.gov Archive Site
Not Provided
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Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)
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
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: MK0773
    Three 25mg oral tablets MK0773 bid, for 12 weeks
  • Drug: Comparator: testosterone enanthate
    intramuscular injection 200mg testosterone enanthate q14d, for 12 weeks
    Other Name: Delatestryl
  • Drug: Comparator: placebo oral tablet
    placebo oral tablet bid, for 12 weeks
  • Drug: Comparator: placebo injection
    placebo intramuscular injection q14d, for 12 weeks
  • Experimental: 1
    MK0773 + placebo injection
    Interventions:
    • Drug: MK0773
    • Drug: Comparator: placebo injection
  • Active Comparator: 2
    placebo to MK0773 + testosterone injection
    Interventions:
    • Drug: Comparator: testosterone enanthate
    • Drug: Comparator: placebo oral tablet
  • Placebo Comparator: 3
    placebo to MK0773 + placebo injection
    Interventions:
    • Drug: Comparator: placebo oral tablet
    • Drug: Comparator: placebo injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
66
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
50 Years to 75 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01017458
0773-004
2009_693
MK-0773-004
Yes
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP