Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT00769418
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2008-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527128', 'term': 'odanacatib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-18', 'studyFirstSubmitDate': '2008-10-06', 'studyFirstSubmitQcDate': '2008-10-08', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of multiple oral doses of MK0822', 'timeFrame': 'After 14 days of treatment for men and 21 days for women'}], 'secondaryOutcomes': [{'measure': 'PK profile of MK0822', 'timeFrame': 'predose and at selected time intervals postdose'}]}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '19421185', 'type': 'BACKGROUND', 'citation': 'Stoch SA, Zajic S, Stone J, Miller DL, Van Dyck K, Gutierrez MJ, De Decker M, Liu L, Liu Q, Scott BB, Panebianco D, Jin B, Duong LT, Gottesdiener K, Wagner JA. Effect of the cathepsin K inhibitor odanacatib on bone resorption biomarkers in healthy postmenopausal women: two double-blind, randomized, placebo-controlled phase I studies. Clin Pharmacol Ther. 2009 Aug;86(2):175-82. doi: 10.1038/clpt.2009.60. Epub 2009 May 6.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a male between the ages of 18 and 45 or a female less than or equal to 70 years of age\n* Females must be past menopause\n* Subject is a nonsmoker\n* Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling\n* Subject is willing to refrain from consuming grapefruit or grapefruit juice\n\nExclusion Criteria:\n\n* Subject has a history of multiple/severe allergies to drugs or food\n* Subject has donated blood within 4 weeks of starting the study\n* Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment\n* Subject has any infections or any condition leading to immune problems, including HIV\n* Subject regularly uses illegal drugs\n* Subject consumes more than 3 alcoholic beverages per day\n* Subject drinks 4 or more caffeinated beverages per day\n* Subject uses any prescription or nonprescription medications'}, 'identificationModule': {'nctId': 'NCT00769418', 'briefTitle': 'Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Multiple Oral Dose Study, to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0822 in Healthy Male and Postmenopausal Female Subjects', 'orgStudyIdInfo': {'id': '0822-002'}, 'secondaryIdInfos': [{'id': 'MK0822-002'}, {'id': '2008_558'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'odanacatib (MK0822)', 'interventionNames': ['Drug: odanacatib']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo to odanacatib (MK0822)', 'interventionNames': ['Drug: Comparator: Placebo']}], 'interventions': [{'name': 'odanacatib', 'type': 'DRUG', 'otherNames': ['MK0822'], 'description': 'Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only.\n\nPanel A: odanacatib tablets 2.5 mg qd for 14 days.\n\nPanel B: odanacatib tablets 5 mg qd for 14 days.\n\nPanel C: odanacatib tablets 10 mg qd for 14 days.\n\nPanel D: odanacatib tablets 25 mg qd for 14 days.\n\nPanel E: odanacatib tablets 0.5 mg qd for 21 days.\n\nPanel F: odanacatib tablets 2.5 mg qd for 21 days.\n\nPanel G: odanacatib tablets 10 mg qd for 21 days.', 'armGroupLabels': ['1']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only.\n\nPanel A: placebo to odanacatib tablets 2.5 mg qd for 14 days.\n\nPanel B: placebo to odanacatib tablets 5 mg qd for 14 days.\n\nPanel C: placebo to odanacatib tablets 10 mg qd for 14 days.\n\nPanel D: placebo to odanacatib tablets 25 mg qd for 14 days.\n\nPanel E: placebo to odanacatib tablets 0.5 mg qd for 21 days.\n\nPanel F: placebo to odanacatib tablets 2.5 mg qd for 21 days.\n\nPanel G: placebo to odanacatib tablets 10 mg qd for 21 days.', 'armGroupLabels': ['2']}]}, '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'}}}}