Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-03-03 @ 8:19 PM
Study NCT ID:
NCT03746106
Status:
COMPLETED
Last Update Posted:
2025-01-03
First Post:
2018-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001602', 'term': 'Beriberi'}, {'id': 'D013832', 'term': 'Thiamine Deficiency'}], 'ancestors': [{'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D013938', 'term': 'Thymidine Monophosphate'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D013831', 'term': 'Thiamine'}], 'ancestors': [{'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013942', 'term': 'Thymine Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D003854', 'term': 'Deoxyribonucleotides'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kathy.giacomini@ucsf.edu', 'phone': '4155144363', 'title': 'Dr. Kathleen Giacomini', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Two cycles (which were separated by a washout period of 5-14 days) and each cycle was three days in duration.', 'description': "The safty population included all participants who received the drug. The National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 should be used to assess and grade adverse event severity, including laboratory abnormalities judged to be clinically significant.", 'eventGroups': [{'id': 'EG000', 'title': 'Thiamine Alone', 'description': 'Participants who received 5 mg thiamine in 500 mL of water in either the first or second cycle of the study.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Thiamine Co-administered With Trimethoprim', 'description': 'Participants who received a combination of 5 mg thiamine and 300 mg trimethoprim with 500 mL of water in either the first or second cycle of the study.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Concentration (Cmax) of Thiamine in Plasma Between the Combination Arm(s) and Single Agent Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thiamine Alone', 'description': 'Participants who received 5 mg thiamine in 500 mL of water in either the first or second cycle of the study.'}, {'id': 'OG001', 'title': 'Thiamine Co-administered With Trimethoprim', 'description': 'Participants who received a combination of 5 mg thiamine and 300 mg trimethoprim with 500 mL of water in either the first or second cycle of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '32', 'spread': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The highest concentration of a thiamine observed in the blood plasma after drug administration', 'description': 'Plasma samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose for each cycle. Cmax is determined by taking blood samples at various time points after drug administration and analyzing the thiamine concentration in plasma.', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From 0 to 24 (AUC0-24)Hours of Thiamine in Plasma Between the Combination Arm(s) and Single Agent Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thiamine Alone', 'description': 'Participants who received 5 mg thiamine in 500 mL of water in either the first or second cycle of the study.'}, {'id': 'OG001', 'title': 'Thiamine Co-administered With Trimethoprim', 'description': 'Participants who received a combination of 5 mg thiamine and 300 mg trimethoprim with 500 mL of water in either the first or second cycle of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '30', 'groupId': 'OG000'}, {'value': '189', 'spread': '138', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose for each cycle.', 'description': 'Plasma samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose for each cycle. AUC0-24 (Area Under the Curve from 0 to 24 hours) is a pharmacokinetic (PK) parameter that represents the total drug exposure in the body over a 24-hour period. It is calculated as the area under the plasma thiamine concentration vs. time curve (from time zero to 24 hours after drug administration).', 'unitOfMeasure': 'nM*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Thiamine Alone, Then Thiamine Co-administered With Trimethoprim', 'description': 'One day prior to each study visit, participants arrived to collect three thiamine-deficient meals. They were instructed to consume these meals throughout the day, abstaining from other food intake. After an overnight fast, participants returned for their scheduled visit. On the first visit, they received 5 mg thiamine in 500 mL of water. Following a 5-14 day washout period, they repeated the process, this time receiving a combination of 5 mg thiamine and 300 mg trimethoprim with 500 mL of water.'}, {'id': 'FG001', 'title': 'Thiamine Co-administered With Trimethoprim, Then Thiamine Alone', 'description': 'One day prior to each study visit, participants arrived to collect three thiamine-deficient meals. They were instructed to consume these meals throughout the day, abstaining from other food intake. After an overnight fast, participants returned for their scheduled visit. On the first visit, they received a combination of 5 mg thiamine and 300 mg trimethoprim with 500 mL of water. Following a 5-14 day washout period, they repeated the process, this time receiving a 5 mg thiamine in 500 mL of water.'}], 'periods': [{'title': 'Cycle 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Cycle 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '7 subjects were randomized into one of two arms; each arm had two cycles (which were separated by a washout period of 5-14 days), and each cycle was three days in duration. During the Cycle 1, subjects were administered either a) 5 mg thiamine (n = 4) or b) 5 mg thiamine and 300 mg trimethoprim with 500 mL of water (n = 3). And during the Cycle 2, patients receive the other treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Thiamine Alone, Thiamine Co-administered With Trimethoprim', 'description': 'Subjects were randomized into one of two arms; each arm had two cycles (which were separated by a washout period of 5-14 days), and each cycle was three days in duration. During the Cycle 1, subjects were administered either a) 5 mg thiamine (n = 4) or b) 5 mg thiamine and 300 mg trimethoprim with 500 mL of water (n = 3). And during the Cycle 2, patients receive the other treatment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '76', 'spread': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170', 'spread': '7.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '4.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Thiamine (Thiamine arm)', 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '24.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nM', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Thiamine (Trimethoprim + Thiamine arm)', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '4.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nM', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-05', 'size': 319354, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-09T14:36', 'hasProtocol': True}, {'date': '2022-01-18', 'size': 237467, 'label': 'Informed Consent Form: Main ICF Part 2', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-09-09T17:02', 'hasProtocol': False}, {'date': '2022-01-18', 'size': 175004, 'label': 'Informed Consent Form: Screening ICF Part 2', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-09-09T17:03', 'hasProtocol': False}, {'date': '2022-01-18', 'size': 229342, 'label': 'Informed Consent Form: Main ICF', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-09-09T17:04', 'hasProtocol': False}, {'date': '2022-01-18', 'size': 157337, 'label': 'Informed Consent Form: Screening ICF', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_004.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-09-09T17:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Part 1: Three-arm randomized crossover study design Part 2: Two-arm randomized crossover study design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2018-11-08', 'resultsFirstSubmitDate': '2024-09-09', 'studyFirstSubmitQcDate': '2018-11-14', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-11', 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Concentration (Cmax) of Thiamine in Plasma Between the Combination Arm(s) and Single Agent Arm', 'timeFrame': 'The highest concentration of a thiamine observed in the blood plasma after drug administration', 'description': 'Plasma samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose for each cycle. Cmax is determined by taking blood samples at various time points after drug administration and analyzing the thiamine concentration in plasma.'}, {'measure': 'Area Under the Curve From 0 to 24 (AUC0-24)Hours of Thiamine in Plasma Between the Combination Arm(s) and Single Agent Arm', 'timeFrame': 'Plasma samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose for each cycle.', 'description': 'Plasma samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose for each cycle. AUC0-24 (Area Under the Curve from 0 to 24 hours) is a pharmacokinetic (PK) parameter that represents the total drug exposure in the body over a 24-hour period. It is calculated as the area under the plasma thiamine concentration vs. time curve (from time zero to 24 hours after drug administration).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug-induced vitamin deficiency'], 'conditions': ['Vitamin B1 Deficiency', 'Thiamine Deficiency']}, 'descriptionModule': {'briefSummary': "In Part 1, subjects will be administered thiamine, thiamine with metformin, and thiamine with trimethoprim. Part 2 will expand on Part 1 and subjects will be administered thiamine and thiamine with trimethoprim. The goal is to determine whether taking a drug and a vitamin together affects the body's ability to absorb, distribute, and eliminate thiamine (Vitamin B1).", 'detailedDescription': "Thiamine is an essential vitamin meaning humans must consume thiamine from their diet in order to stay healthy. Low thiamine levels can lead to adverse events. Thiamine is absorbed in the intestine by a transporter protein. This is made by the SLC19A3 gene. The SLC19A3 gene provides instructions for making the thiamine transporter protein, which moves thiamine into cells. Certain drugs, like metformin and trimethoprim, have been shown to interrupt function of the SLC19A3 gene.\n\nMetformin is a first-line therapy for patients with Type 2 diabetes and is associated with improvements in diabetic complications. Trimethoprim is an anti-bacterial drug that is often prescribed to treat infections such as urinary tract infections. At different phases of this study, participants will be administered thiamine, thiamine with metformin, and/or thiamine with trimethoprim to determine whether taking a drug and a vitamin together affects the body's ability to absorb, distribute, and eliminate thiamine. The levels of thiamine in the participants' blood and urine will be measured before and after taking thiamine or thiamine in combination with metformin and/or trimethoprim."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female between the ages of 18-65 years old.\n2. Eats a wide variety of food and willing to consume study diet (i.e. not on a specific diet such as Atkins, Fodmap, etc.).\n3. Written informed consent obtained from the subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Subjects who are pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n2. Self-reported severe food allergies or diet restrictions (vegans, vegetarians, Atkins, Fodmap, etc.) that would prevent consumption of study diets.\n3. Subjects with extreme obesity (BMI \\> 35).\n4. Subjects who are smokers or have smoked in the past year and/or have smoked or ingested THC/marijuana in the past week, or who are unwilling to comply with a 1-week washout.\n5. Subjects with any disease affecting or impairing the function of the liver, kidney or heart.\n6. Subjects with moderate to severe hypertension.\n7. Subjects with diabetes mellitus, hyperthyroidism, hypothyroidism, cardiovascular disease, glaucoma.\n8. Subjects with gastrointestinal disease, gastrointestinal disorder, or gastrointestinal surgery.\n9. Subjects with known infection with HIV, Hepatitis B (HBsAg) or Hepatitis C (no laboratory diagnostics concerning these diseases will be performed within the present study. Volunteers who are cured of past HepC infection are eligible to participate with doctor's approval letter).\n10. Alcohol use on average \\> 2 servings/day or \\> 14 servings/wk (Serving size: 12oz beer/4oz wine/2oz hard liquor) or self-reported binge drinking.\n11. Subjects that are on vitamin B supplements or multi-vitamins or who have taken vitamin B supplements or multi-vitamins in the past 30 days, or are not willing to comply with a 30-day washout of vitamin B supplements.\n12. Subjects with possible folate deficiency.\n13. Subjects taking any other clinically significant drugs as judged by the investigator.\n14. Subjects with a condition, disease, or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n15. Female subjects undergoing treatment for infertility or hormone replacement therapy (Volunteers using hormonal birth control will not be excluded).\n16. Subjects who have taken antimalarials in the past 60 days.\n17. Participating in another research study while participating in this research study.\n18. Non-English speaking\n19. Subjects with abnormal laboratory results at screening as judged by the investigator or study physician."}, 'identificationModule': {'nctId': 'NCT03746106', 'briefTitle': 'The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine', 'orgStudyIdInfo': {'id': '13060'}, 'secondaryIdInfos': [{'id': '5R01DK108722-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01DK108722-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thiamine only', 'description': '5mg thiamine tablet by mouth. This arm will be included in both Parts 1 and 2 of the study.', 'interventionNames': ['Dietary Supplement: Vitamin B1']}, {'type': 'EXPERIMENTAL', 'label': 'Trimethporim + thiamine combination', 'description': '5mg thiamine tablet and 300mg trimethoprim tablet by mouth. This arm will be included in both Parts 1 and 2 of the study.', 'interventionNames': ['Drug: Trimethoprim', 'Dietary Supplement: Vitamin B1']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin + thiamine combination', 'description': '5mg thiamine tablet and 1000mg metformin tablet by mouth. This arm will be included in only Part 1 of the study.', 'interventionNames': ['Drug: Metformin', 'Dietary Supplement: Vitamin B1']}], 'interventions': [{'name': 'Trimethoprim', 'type': 'DRUG', 'otherNames': ['Primsol'], 'description': '300mg of trimethoprim will be given in combination with 5mg thiamine and compared to 5mg thiamine only for both Parts 1 and 2 of the study.', 'armGroupLabels': ['Trimethporim + thiamine combination']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': '1000mg of metformin will be given in combination with 5mg thiamine and compared to 5mg thiamine only in Part 1 of the study.', 'armGroupLabels': ['Metformin + thiamine combination']}, {'name': 'Vitamin B1', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Thiamine'], 'description': '5mg of thiamine will be given alone and in combination for both Parts 1 and 2 of the study.', 'armGroupLabels': ['Metformin + thiamine combination', 'Thiamine only', 'Trimethporim + thiamine combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Jean Mayer USDA Human Nutrition Research Center on Aging', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Kathleen M Giacomini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Andrew S Greenberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tufts University', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'University of California, Davis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}