Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT00651534
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2008-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Estimate Relative Bioavailability of 5 Formulations of Ronacaleret Given to Healthy Postmenopausal Females
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': 'C561716', 'term': 'ronacaleret'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'enrollmentInfo': {'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2016-04-28', 'studyFirstSubmitDate': '2008-03-28', 'studyFirstSubmitQcDate': '2008-03-28', 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-02', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Formulation Drug Study, healthy postmenopausal'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy postmenopausal women\n* Non-smokers\n* Body weight \\> or = 50 kg and BMI within the range 19-32 kg/m2\n* Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form\n* QTcB or QTcF \\< 450 msec; or QTc \\< 480 msec in subjects with Bundle Branch Block\n* Hispanic or non-Hispanic (Caucasian) ethnicity\n\nExclusion criteria:\n\n* Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study\n* Positive urine drug screen at screening\n* Positive urine test for alcohol at pre-dose\n* Positive for HIV or hepatitis B or C virus at screening\n* Urinary cotinine levels indicative of smoking at screening\n* History of smoking or use of nicotine containing products within one year of the study or \\>10 pack-year history of smoking overall\n* History of regular alcohol consumption exceeding 7 units/week (1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening\n* History of drug abuse within 6 months of the study\n* Participation in a clinical study and received a drug or a new chemical entity with 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of the current study medication.\n* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.\n* Use of prescription or non-prescription drugs\n* Consumption of red wine, grapefruit, grapefruit juice or grapefruit containing products within 14 days prior to the first dose of study medication\n* Donation of blood in excess of 500 mL within 56 days prior to dosing\n* Evidence of renal, hepatic or biliary impairment\n* History of serious gastrointestinal disease\n* History of sensitivity to any of the study medications or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.\n* History of clinically significant cardiovascular disease\n* Medical conditions that might alter bone metabolism\n* Serum parathyroid hormone (iPTH) test levels outside the reference range at screening\n* Liver function tests, parathyroid hormone test or CPK outside the reference range at screening'}, 'identificationModule': {'nctId': 'NCT00651534', 'briefTitle': 'To Estimate Relative Bioavailability of 5 Formulations of Ronacaleret Given to Healthy Postmenopausal Females', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-label, Randomized, Five Period Crossover Study to Estimate the Relative Bioavailability of Five Formulations of 400 mg Ronacaleret (a Calcium-sensing Receptor Antagonist) Administered as a Single Oral Dose to Healthy Postmenopausal Females.', 'orgStudyIdInfo': {'id': 'CR9106341'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ronacaleret', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}