A Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (MK-0000-064)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00816712
First received: December 31, 2008
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

This is a study to evaluate the use of fractional synthetic rate as an early biomarker of muscle anabolism (muscle build-up).


Condition Intervention Phase
Muscle Anabolism
Drug: Comparator: Testosterone 300 mg, intramuscular injection
Drug: Comparator: Testosterone 100 mg, Intramuscular injection
Drug: Comparator: Placebo given by Intramuscular Injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Blind, Placebo-Controlled, Single-dose, Parallel Design Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (FSR)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone. [ Time Frame: One week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Variability in the muscle fractional synthetic rate measurements. [ Time Frame: One week ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Testosterone - 300 mg IM
Drug: Comparator: Testosterone 300 mg, intramuscular injection

Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.

Day 1 & 7 - Testosterone 300 mg, Intramuscular injection.

Active Comparator: B
Testosterone - 100 mg IM
Drug: Comparator: Testosterone 100 mg, Intramuscular injection

Day 1 & 7- Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.

Day 1 & 7 - Testosterone 100 mg, Intramuscular injection.

Placebo Comparator: C
Placebo - IM
Drug: Comparator: Placebo given by Intramuscular Injection

Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.

Day 1 & 7 - Placebo given as intramuscular injection.


  Eligibility

Ages Eligible for Study:   60 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is weight stable over the past 3 months
  • Patient agrees to refrain from consumption of alcohol from 48 hours prior to entering the study
  • Subject agrees to follow the study restriction of no caffeine while on study
  • Patient agrees to following the meat-free controlled protein weight-maintaining diet
  • Patient is willing to avoid strenuous physical activity
  • Patient has been a nonsmoker for at least 6 months prior to study start

Exclusion Criteria:

  • Subject is currently a regular user of any illicit drugs
  • Subject has taken androgenic steroids in the previous 12 months
  • Subject has participated in sports events, resistance exercise training or heavy exercise in the previous month
  • Subject has prostate cancer
  • Subject has a history of cancer except basal-cell tumors
  • Subject has been diagnosed with HIV
  • Subject has been diagnosed with Hepatitis B or C
  • Subject uses certain anti-inflammatory drugs such as ibuprofen, arcoxia or celecoxib
  • Subject uses a blood anticoagulant, such as Coumadin (Warfarin) or high doses of aspirin
  • Subject is currently taking over the counter supplements such as "muscle builders" or "fat burners"
  • Subject has an allergy or hypersensitivity to intramuscular testosterone
  • Subject has sciatica
  • Subject has donated blood products or has had phlebotomy within 2 months of signing informed consent
  • Subject has undergone a surgical procedure within 1 month of signing informed consent
  • Subject is currently participating or has participated in a study with an investigational drug or device
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816712

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00816712     History of Changes
Other Study ID Numbers: 0000-064, 2008_604
Study First Received: December 31, 2008
Last Updated: March 7, 2014
Health Authority: Ireland: Irish Medicines Board

Keywords provided by Merck Sharp & Dohme Corp.:
Males with low-normal serum total testosterone levels.

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 28, 2014