24 completed, 2 terminated. 18 Phase 1, 2 Phase 4, 1 Not applicable, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 18 | Completed 16, Terminated 2 |
| Phase 4 | 2 | Completed 2 |
| Not applicable | 1 | Completed 1 |
| Phase 2 | 1 | Completed 1 |
Follow Tolbutamide: new trials by email Literature Review of Tolbutamide trials Research Report on Tolbutamide
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Trial to Evaluate the Impact of C21 on the Exposure of 4 Substrates in Healthy Volunteers Drug Drug Interaction - Drug Interaction | Phase 1 | Completed | Vicore Pharma AB | 19 | 2023-03-29 | 2025-01-03 |
| Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide Ritlecitinib, Tolbutamide - Healthy Volunteers | Phase 1 | Completed | Pfizer | 12 | 2021-11-02 | 2023-10-06 |
| Phenotyping of High Dose Rifampicin phenotyping cocktail, rifampicin - Tuberculosis | Phase 1 | Completed | Radboud University Medical Center | 25 | 2021-01-07 | 2021-08-17 |
| Licorice Botanical Dietary Supplements - Metabolism and Safety in Women Licorice, Alprazolam 2 MG, Caffeine 100 MG - Food-drug Interaction | Phase 1 | Completed | University of Illinois at Chicago | 19 | 2019-04-01 | 2023-05-06 |
| A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib tucatinib, itraconazole, rifampin - Drug-drug Interaction | Phase 1 | Completed | Seagen Inc. | 116 | 2018-09-17 | 2019-12-18 |
| Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s Midazolam hydrochloride, Metoprolol tartrate, Pioglitazone hydrochloride - Healthy | Phase 1 | Completed | Corcept Therapeutics | 27 | 2018-03-06 | 2018-05-17 |
| Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics) Tolbutamide, Midazolam, Pexidartinib - Drug Interaction Potential | Phase 1 | Completed | Daiichi Sankyo | 32 | 2018-02-26 | 2021-05-14 |
| A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers Nitisinone in Arm A, Tolbutamide, Metoprolol - Drug Drug Interaction | Phase 1 | Completed | Swedish Orphan Biovitrum | 36 | 2017-03-28 | 2017-08-10 |
| Drug Interaction Study of CT1812 in Healthy Volunteers CT1812, tolbutamide, dextromethorphan - Healthy Volunteers | Phase 1 | Completed | Cognition Therapeutics | 16 | 2016-11-10 | 2018-10-23 |
| Effect of Acute Ethanol Consumption on The Activity of Major Cytochrome P450 Enzymes, NAT2 and P-glycoprotein caffeine, tolbutamide, omeprazole, dextromethorphan, digoxin, midazolam single doses, ethanol multiple doses plus caffeine, tolbutamide, omeprazole, dextromethorphan, digoxin, midazolam single doses - AOD Effects and Consequences | Not applicable | Completed | University of Cologne | 16 | 2015-06-01 | 2019-09-09 |
| A PHASE 1, OPEN-LABEL, CROSS-OVER, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF MULTIPLE DOSES OF DS-1971A ON THE SINGLE DOSE PHARMACOKINETICS OF PROBE SUBSTRATES FOR CYP2B6, CYP2C8, CYP2C9, CYP2C19 AND CYP3A4 ENZYMES IN HEALTHY MALE AND FEMALE SUBJECTS DS-1971a, midazolam hydrochloride, Omeprazole - Healthy | Phase 1 | Completed | Daiichi Sankyo | 18 | 2015-05-01 | 2015-11-05 |
| Evaluation of CYP450 Activities in Diabetic Patients vs. Non-diabetic Subjects CRCHUM-MT cocktail - Type 2 Diabetes | Phase 4 | Completed | Centre hospitalier de l'Université de Montréal (CHUM) | 73 | 2015-04-01 | 2019-07-23 |
| A Study to Assess Effect of JNJ-54861911 on Pharmacokinetics of Cocktail Representatives for Cytochrome P450 (CYP) 3A4, CYP2B6, CYP2C9, and CYP1A2 Substrates JNJ-54861911, Caffeine, Midazolam - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 16 | 2014-09-01 | 2015-11-24 |
| Incretin-based Drugs and the Risk of Heart Failure DPP-4 inhibitors, GLP-1 analogs, Insulins - Type 2 Diabetes Mellitus | Completed | Canadian Network for Observational Drug Effect Studies, CNODES | 1499650 | 2014-03-01 | 2016-04-19 | |
| Incretin-based Drugs and Acute Pancreatitis DPP-4 inhibitors, GLP-1 analogs, Insulins - Diabetes Mellitus, Type 2 | Completed | Canadian Network for Observational Drug Effect Studies, CNODES | 1417914 | 2014-03-01 | 2016-11-03 | |
| Incretin-based Drugs and Pancreatic Cancer DPP-4 inhibitors, GLP-1 analogs, Sulfonylureas - Diabetes Mellitus, Type 2 | Completed | Canadian Network for Observational Drug Effect Studies, CNODES | 886172 | 2014-03-01 | 2016-03-14 | |
| Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients midazolam, BI 201335, tenofovir - Hepatitis C, Chronic | Phase 1 | Completed | Boehringer Ingelheim | 72 | 2012-04-01 | 2016-06-10 |
| Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced Solid Tumors Gamma-Secretase Inhibitor RO4929097, Ketoconazole, Rifampin - Adult Solid Neoplasm | Phase 1 | Completed | National Cancer Institute (NCI) | 17 | 2010-09-01 | 2014-12-23 |
| A Pharmacokinetic Evaluation of Metformin in Relation to the Polymorphism A270S in Healthy Caucasian Volunteers Metformin - Metformin, Organic Cation Transporter 2 | Phase 4 | Completed | University of Southern Denmark | 50 | 2010-08-01 | 2010-12-29 |
| A Drug Interaction Study of Tasisulam in Patients With Advanced Cancer or Lymphoma Tolbutamide, Tasisulam - Lymphoma, Advanced Cancer | Phase 1 | Terminated | Eli Lilly and Company | 4 | 2010-07-01 | 2018-10-19 |
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Diabetes Mellitus, Type 2 (6) · Alzheimer Disease (1) · Chronic Pain (1) · Diabetes Mellitus (1) · Endotoxemia (1) · Glucose Intolerance (1) · Heart Failure (1) · Hepatitis C, Chronic (1) · Inflammation (1) · Lymphoma (1) · Metabolic Syndrome (1) · Pancreatic Neoplasms (1) · Pancreatitis (1) · Synovitis, Pigmented Villonodular (1) · Tuberculosis (1)
Canadian Network for Observational Drug Effect Studies, CNODES (3) · Boehringer Ingelheim (2) · Daiichi Sankyo (2) · Radboud University Medical Center (2) · AstraZeneca (1) · Centre hospitalier de l'Université de Montréal (CHUM) (1) · Cognition Therapeutics (1) · Corcept Therapeutics (1) · Eli Lilly and Company (1) · Janssen Research & Development, LLC (1) · National Cancer Institute (NCI) (1) · Novartis (1) · Pfizer (1) · Repros Therapeutics Inc. (1) · Seagen Inc. (1)
United States (11) · Canada (6) · Germany (4) · United Kingdom (3) · Netherlands (2) · Australia (1) · Denmark (1) · Finland (1) · India (1) · Italy (1) · New Zealand (1) · South Africa (1) · Sweden (1) · Taiwan (1)
Pierre Ernst, MD, MSc (3) · Alex Vo, PhD (1) · Alyssa Galley (1) · Biljana Lilja (1) · George Wilding (1) · Jean-Louis Chiasson, MD (1) · Kim Broesen, Professor (1) · Kirsteen Donaldson, FFPM,DM,FRCP (1)
PMID 16864730, PMID 26888382, PMID 27007958, PMID 27479930, PMID 29439084, PMID 31099895, PMID 32719417, PMID 33289960, PMID 35931943, PMID 37768317, PMID 39368039
2014 (1), 2016 (1), P30CA014520 (1), R01GM069753 (1), U01CA062491 (1)