Safety and Tolerability of MK0773 in Healthy Older Men - Full Text View

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:

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate

U.S. FDA Resources

Further study details as provided by Merck:

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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT01017458 History of Changes
Other Study ID Numbers:	2009_693, MK0773-004
Study First Received:	November 18, 2009
Last Updated:	November 19, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Healthy Adults

Additional relevant MeSH terms:

Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on June 18, 2013