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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01017458
First received: November 18, 2009
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: MK0773
Drug: Comparator: testosterone enanthate
Drug: Comparator: placebo oral tablet
Drug: Comparator: placebo injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of subjects with Clinical Adverse Events (CAE) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Serious CAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with drug-related CAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious drug-related CAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects that discontinued with CAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Laboratory Adverse Events (LAE) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with drug-related LAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious LAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious drug-related LAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects that discontinued with LAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0773 + placebo injection
Drug: MK0773
Three 25mg oral tablets MK0773 bid, for 12 weeks
Drug: Comparator: placebo injection
placebo intramuscular injection q14d, for 12 weeks
Active Comparator: 2
placebo to MK0773 + testosterone injection
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
Placebo Comparator: 3
placebo to MK0773 + placebo injection
Drug: Comparator: placebo oral tablet
placebo oral tablet bid, for 12 weeks
Drug: Comparator: placebo injection
placebo intramuscular injection q14d, for 12 weeks

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017458

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01017458     History of Changes
Other Study ID Numbers: 0773-004, 2009_693, MK-0773-004
Study First Received: November 18, 2009
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Healthy Adults

Additional relevant MeSH terms:
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014