Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-02 @ 4:07 AM
Study NCT ID:
NCT01546558
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
2012-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000069458', 'term': 'Ranolazine'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-09', 'studyFirstSubmitDate': '2012-02-27', 'studyFirstSubmitQcDate': '2012-03-06', 'lastUpdatePostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of metformin', 'timeFrame': '0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5 and 10'}, {'measure': 'Area under the plasma concentration vs time curve over the dosing interval, at steady state (AUCtau) of metformin', 'timeFrame': '0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5 and 10'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'From time of signed informed consent to time of follow-up phone call, an expected average of 5 weeks'}, {'measure': 'Maximum observed plasma concentration (Cmax) of ranolazine and metabolites', 'timeFrame': '0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 10'}, {'measure': 'Area under the plasma concentration versus time curve over the dosing interval, at steady state (AUCtau) of ranolazine and metabolites', 'timeFrame': '0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metformin', 'Ranolazine', 'Type 2 Diabetes Mellitus'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of steady-state ranolazine 500 mg bid on the steady state pharmacokinetics (PK) of metformin in subjects with type 2 diabetes mellitus (T2DM).', 'detailedDescription': 'The primary objective of this study is as follows:\n\n• To evaluate the effect of steady-state ranolazine 500 mg twice daily (bid) on the steady state pharmacokinetics (PK) of metformin in subjects with T2DM.\n\nThe secondary objectives of this study are as follows:\n\n* To examine the safety and tolerability of metformin when co administered with ranolazine 500 mg bid at steady-state in subjects with T2DM.\n* To determine the steady-state PK of ranolazine 500 mg bid in subjects with T2DM receiving metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, 30 to 65 years old, inclusive\n* Documented history of T2DM\n* HbA1c 6.5%-10%, inclusive\n* Fasting serum glucose ≤ 270 mg/dL at Screening\n* Fasting C-peptide ≥ 1 ng/mL at Screening\n* Stable metformin monotherapy (metformin ≥ 1500 mg total daily dose for at least 4 weeks prior to Screening)\n* Body mass index (BMI) 25 to 40 kg/m2, inclusive, at Screening\n* Creatinine Clearance \\> 80 mL/min at Screening\n* Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1 and must agree to use highly effective contraception methods from Screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug\n\nExclusion Criteria:\n\n* Type 1 Diabetes Mellitus (T1DM)\n* Use of insulin therapy \\< 3 months prior to Screening\n* History of ketoacidosis, ketosis-prone diabetes, or lactic acidosis\n* Clinically significant complications of diabetes\n* History of hypoglycemia\n* Any non-insulin antidiabetic therapy (other than metformin) \\< 2 months prior to Screening\n* Any clinically significant cardiovascular event \\< 2 months prior to Screening\n* Clinically significant, inadequately controlled, or unstable hypertension\n* Hospitalization \\< 2 months prior to Screening or major surgery \\< 3 months prior to Screening\n* History of gastrointestinal disease or surgery that could impact drug absorption\n* History of substance of alcohol or substance abuse\n* Positive urine drug screen for drugs of abuse\n* Positive alcohol breath test\n* Any other clinically significant existing medical or psychiatric condition or one requiring further evaluation\n* Treatment with selected medications\n* Hemoglobin \\< 12 g/dL for males; or \\< 11 g/dL for females at Screening\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2.5x upper limits of normal\n* Clinically significant history of hepatic disease or evidence of hepatic impairment\n* Positive blood screen for hepatitis C or hepatitis B\n* QTc interval \\> 500 msec at Screening\n* Females who are pregnant or are breastfeeding'}, 'identificationModule': {'nctId': 'NCT01546558', 'briefTitle': 'Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 1, Open-label, Single Cohort, Two-Period Fixed Sequence Study to Assess the Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg Twice Daily in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'GS-US-259-0143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin, Ranolazine', 'description': 'Single cohort, 2-period study:\n\n* Period 1, metformin 1000 mg bid on Days 1-5\n* Period 2, metformin 1000 mg bid + ranolazine 500 mg bid on Days 6-10', 'interventionNames': ['Drug: Metformin', 'Drug: Ranolazine']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Metformin 1000 mg bid on Days 1-10', 'armGroupLabels': ['Metformin, Ranolazine']}, {'name': 'Ranolazine', 'type': 'DRUG', 'otherNames': ['Ranexa'], 'description': 'Ranolazine 500 mg bid on Days 6-10', 'armGroupLabels': ['Metformin, Ranolazine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'SeaView Research Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Axel Juan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SeaView Research, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}