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The purpose of the study if to evaluate the effect of Repotrectinib on the drug levels of transporter and CYP P450 probe substrates in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repotrectinib | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of AUC (0-T) of Probe Substrate With Repotrectinib | Probe substrate contains metformin, digoxin, and rosuvastatin. | Up to approximately Day 17 post dose |
| Cohort 1: AUC (0-T) of Probe Substrate Without Repotrectinib | Probe substrate contains metformin, digoxin, and rosuvastatin. | Up to approximately Day 17 post dose |
| Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Probe Substrate With Repotrectinib | Probe substrate contains metformin, digoxin, and rosuvastatin. | Up to approximately Day 17 post dose |
| Cohort 1: AUC(INF) of Probe Substrate Without Repotrectinib | Probe substrate contains metformin, digoxin, and rosuvastatin. | Up to approximately Day 17 post dose |
| Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Probe Substrate With Repotrectinib | Probe substrate contains metformin, digoxin, and rosuvastatin | Up to approximately Day 17 post dose |
| Cohort 1: Cmax of Probe Substrate Without Repotrectinib | Probe substrate contains metformin, digoxin, and rosuvastatin | Up to approximately Day 17 post dose |
| Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to 48 Hours Post Dose (AUC (0-48)) of Metformin With Repotrectinib |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to approximately Day 45 post dose | |
| Number of Participants with Serious Adverse Events (SAEs) | Up to approximately Day 45 post dose | |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Daytona Beach | Florida | 32117-5116 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| Metformin |
| Drug |
Specified dose on specified days |
|
| Digoxin | Drug | Specified dose on specified days |
|
| Rosuvastatin | Drug | Specified dose on specified days |
|
| Bupropion | Drug | Specified dose on specified days |
|
| Flurbiprofen | Drug | Specified dose on specified days |
|
| Omeprazole | Drug | Specified dose on specified days |
|
| Up to approximately Day 17 post dose |
| Cohort 1: AUC (0-48) of Metformin Without Repotrectinib | Up to approximately Day 17 post dose |
| Cohort 1: Renal Clearance (CLR) of Metformin in Urine | Up to approximately Day 16 post dose |
| Cohort 2: AUC (0-T) of Probe Substrate With Repotrectinib | Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole) | Up to approximately Day 17 post dose |
| Cohort 2: AUC (0-T) of Probe Substrate Without Repotrectinib | Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole) | Up to approximately Day 17 post dose |
| Cohort 2: AUC (INF) of Probe Substrate With Repotrectinib | Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole) | Up to approximately Day 17 post dose |
| Cohort 2: AUC (INF) of Probe Substrate Without Repotrectinib | Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole) | Up to approximately Day 17 post dose |
| Cohort 2: Cmax of Probe Substrate With Repotrectinib | Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole) | Up to approximately Day 17 post dose |
| Cohort 2: Cmax of Probe Substrate Without Repotrectinib | Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole) | Up to approximately Day 17 post dose |
| Number of Participants With Clinically Significant Physical Examination Findings |
| Up to approximately Day 17 post dose |
| Number of Participants With Clinically Significant Vital Sign Measurements | Up to approximately Day 17 post dose |
| Number of Participants With Clinically Significant 12-lead Electrocardiogram (12-lead ECG) Findings | Up to approximately Day 17 post dose |
| Number of Participants With Clinically Significant Safety Laboratory Test Results | Up to approximately Day 17 post dose |
| ID | Term |
|---|---|
| C000708510 | repotrectinib |
| D008687 | Metformin |
| D004077 | Digoxin |
| D000068718 | Rosuvastatin Calcium |
| D016642 | Bupropion |
| D005480 | Flurbiprofen |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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