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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: MK0773; Drug: Comparator: placebo injection; Drug: Comparator: testosterone enanthate; Drug: Comparator: placebo oral tablet

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Delatestryl; Drug: Comparator: placebo oral tablet; placebo oral tablet bid, for 12 weeks
Placebo Comparator: 3; placebo to MK0773 + placebo injection	Drug: Comparator: placebo injection; placebo intramuscular injection q14d, for 12 weeks; Drug: Comparator: placebo oral tablet; placebo oral tablet bid, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with Clinical Adverse Events (CAE)	12 weeks
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 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
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: November 18, 2009
• First Submitted That Met QC Criteria: November 19, 2009
• First Posted (Estimate): November 20, 2009

Study Record Updates

• Last Update Posted (Estimate): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Healthy Adults
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: 0773-004; 2009_693; MK-0773-004