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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Comparator: placebo injection
Drug: MK0773
Drug: Comparator: testosterone enanthate
Drug: Comparator: placebo oral tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01017458
2009_693
MK-0773-004
0773-004

Details and patient eligibility

About

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

Enrollment

68 patients

Sex

Male

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

68 participants in 3 patient groups, including a placebo group

1
Experimental group
Description:
MK0773 + placebo injection
Treatment:
Drug: Comparator: placebo injection
Drug: MK0773
2
Active Comparator group
Description:
placebo to MK0773 + testosterone injection
Treatment:
Drug: Comparator: placebo oral tablet
Drug: Comparator: testosterone enanthate
3
Placebo Comparator group
Description:
placebo to MK0773 + placebo injection
Treatment:
Drug: Comparator: placebo oral tablet
Drug: Comparator: placebo injection

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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