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Completed

NCT Number: NCT01017458

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

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

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Key information

Conditions

Healthy

Age range

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0773

Drug

Three 25mg oral tablets MK0773 bid, for 12 weeks

Comparator: testosterone enanthate

Drug

intramuscular injection 200mg testosterone enanthate q14d, for 12 weeks

Other names: Delatestryl

Comparator: placebo oral tablet

Drug

placebo oral tablet bid, for 12 weeks

Comparator: placebo injection

Drug

placebo intramuscular injection q14d, for 12 weeks

Primary outcomes

  1. Number of subjects with Clinical Adverse Events (CAE)

    Time frame: 12 weeks

  2. Number of subjects with Serious CAEs

    Time frame: 12 weeks

  3. Number of subjects with drug-related CAEs

    Time frame: 12 weeks

  4. Number of subjects with serious drug-related CAEs

    Time frame: 12 weeks

  5. Number of subjects that discontinued with CAEs

    Time frame: 12 weeks

  6. Number of subjects with Laboratory Adverse Events (LAE)

    Time frame: 12 weeks

  7. Number of subjects with drug-related LAEs

    Time frame: 12 weeks

  8. Number of subjects with serious LAEs

    Time frame: 12 weeks

  9. Number of subjects with serious drug-related LAEs

    Time frame: 12 weeks

  10. Number of subjects that discontinued with LAEs

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 20, 2009
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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