NCT01017458

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

November 18, 2009

Last Update Submit

July 11, 2016

Conditions

Healthy

Keywords

Healthy Adults

Outcome Measures

Primary Outcomes (10)

  • 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

Study Arms (3)

1

EXPERIMENTAL

MK0773 + placebo injection

Drug: MK0773Drug: Comparator: placebo injection

2

ACTIVE COMPARATOR

placebo to MK0773 + testosterone injection

Drug: Comparator: testosterone enanthateDrug: Comparator: placebo oral tablet

3

PLACEBO COMPARATOR

placebo to MK0773 + placebo injection

Drug: Comparator: placebo oral tabletDrug: Comparator: placebo injection

Interventions

MK0773DRUG

Three 25mg oral tablets MK0773 bid, for 12 weeks

1
Comparator: testosterone enanthateDRUG

intramuscular injection 200mg testosterone enanthate q14d, for 12 weeks

Also known as: Delatestryl
2
Comparator: placebo oral tabletDRUG

placebo oral tablet bid, for 12 weeks

23
Comparator: placebo injectionDRUG

placebo intramuscular injection q14d, for 12 weeks

13

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

3-fluoro-N-(3H-imidazo(4,5-b)pyridin-2-ylmethyl)-1,4a,6a-trimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-1H-indeno(5,4-f)quinoline-7-carboxamidetestosterone enanthate

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 20, 2009

Study Start

June 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

July 12, 2016

Record last verified: 2016-07