Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT00816712
Status:
COMPLETED
Last Update Posted:
2015-02-13
First Post:
2008-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (MK-0000-064)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007273', 'term': 'Injections, Intramuscular'}], 'ancestors': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-12', 'studyFirstSubmitDate': '2008-12-31', 'studyFirstSubmitQcDate': '2009-01-02', 'lastUpdatePostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone.', 'timeFrame': 'One week'}], 'secondaryOutcomes': [{'measure': 'Variability in the muscle fractional synthetic rate measurements.', 'timeFrame': 'One week'}]}, 'conditionsModule': {'keywords': ['Males with low-normal serum total testosterone levels.'], 'conditions': ['Muscle Anabolism']}, 'referencesModule': {'references': [{'pmid': '21475673', 'type': 'RESULT', 'citation': 'Chen F, Lam R, Shaywitz D, Hendrickson RC, Opiteck GJ, Wishengrad D, Liaw A, Song Q, Stewart AJ, Cummings CE, Beals C, Yarasheski KE, Reicin A, Ruddy M, Hu X, Yates NA, Menetski J, Herman GA. Evaluation of early biomarkers of muscle anabolic response to testosterone. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):45-56. doi: 10.1007/s13539-011-0021-y. Epub 2011 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate the use of fractional synthetic rate as an early biomarker of muscle anabolism (muscle build-up).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is weight stable over the past 3 months\n* Patient agrees to refrain from consumption of alcohol from 48 hours prior to entering the study\n* Subject agrees to follow the study restriction of no caffeine while on study\n* Patient agrees to following the meat-free controlled protein weight-maintaining diet\n* Patient is willing to avoid strenuous physical activity\n* Patient has been a nonsmoker for at least 6 months prior to study start\n\nExclusion Criteria:\n\n* Subject is currently a regular user of any illicit drugs\n* Subject has taken androgenic steroids in the previous 12 months\n* Subject has participated in sports events, resistance exercise training or heavy exercise in the previous month\n* Subject has prostate cancer\n* Subject has a history of cancer except basal-cell tumors\n* Subject has been diagnosed with HIV\n* Subject has been diagnosed with Hepatitis B or C\n* Subject uses certain anti-inflammatory drugs such as ibuprofen, arcoxia or celecoxib\n* Subject uses a blood anticoagulant, such as Coumadin (Warfarin) or high doses of aspirin\n* Subject is currently taking over the counter supplements such as "muscle builders" or "fat burners"\n* Subject has an allergy or hypersensitivity to intramuscular testosterone\n* Subject has sciatica\n* Subject has donated blood products or has had phlebotomy within 2 months of signing informed consent\n* Subject has undergone a surgical procedure within 1 month of signing informed consent\n* Subject is currently participating or has participated in a study with an investigational drug or device'}, 'identificationModule': {'nctId': 'NCT00816712', 'briefTitle': 'A Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (MK-0000-064)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Single-Blind, Placebo-Controlled, Single-dose, Parallel Design Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (FSR)', 'orgStudyIdInfo': {'id': '0000-064'}, 'secondaryIdInfos': [{'id': '2008_604'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Testosterone - 300 mg IM', 'interventionNames': ['Drug: Comparator: Testosterone 300 mg, intramuscular injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Testosterone - 100 mg IM', 'interventionNames': ['Drug: Comparator: Testosterone 100 mg, Intramuscular injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'description': 'Placebo - IM', 'interventionNames': ['Drug: Comparator: Placebo given by Intramuscular Injection']}], 'interventions': [{'name': 'Comparator: Testosterone 300 mg, intramuscular injection', 'type': 'DRUG', 'description': 'Day 1 \\& 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.\n\nDay 1 \\& 7 - Testosterone 300 mg, Intramuscular injection.', 'armGroupLabels': ['A']}, {'name': 'Comparator: Testosterone 100 mg, Intramuscular injection', 'type': 'DRUG', 'description': 'Day 1 \\& 7- Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.\n\nDay 1 \\& 7 - Testosterone 100 mg, Intramuscular injection.', 'armGroupLabels': ['B']}, {'name': 'Comparator: Placebo given by Intramuscular Injection', 'type': 'DRUG', 'description': 'Day 1 \\& 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.\n\nDay 1 \\& 7 - Placebo given as intramuscular injection.', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}