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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01017458

Enrollment

Registered

2009-11-20

Start date

2007-06-30

Completion date

2008-08-31

Last updated

2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Adults

Brief summary

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

Interventions

DRUGMK0773

Three 25mg oral tablets MK0773 bid, for 12 weeks

DRUGComparator: testosterone enanthate

intramuscular injection 200mg testosterone enanthate q14d, for 12 weeks

DRUGComparator: placebo oral tablet

placebo oral tablet bid, for 12 weeks

DRUGComparator: placebo injection

placebo intramuscular injection q14d, for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

50 Years to 75 Years

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026