Muscle Anabolism
Conditions
Keywords
Males with low-normal serum total testosterone levels.
Brief summary
This is a study to evaluate the use of fractional synthetic rate as an early biomarker of muscle anabolism (muscle build-up).
Interventions
DRUGComparator: 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.
DRUGComparator: 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.
DRUGComparator: 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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
60 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone. | One week |
Secondary
| Measure | Time frame |
|---|---|
| Variability in the muscle fractional synthetic rate measurements. | One week |
Outcome results
None listed