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The purpose of this study is to evaluate the effects of coadministration of voriconazole or quinidine on the pharmacokinetics (PK) of repotrectinib in healthy male and female (individual not of childbearing potential [INOCBP]) participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repotrectinib | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 23 | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 23 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Up to Day 52 | |
| Number of participants with Severe Adverse Events (SAEs) | Up to Day 52 | |
| Number of participants with physical examination abnormalities |
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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 |
|---|---|---|---|---|---|---|
| Fortrea - Daytona Beach | Daytona Beach | Florida | 32117 | 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/disclosurecommitment.html
See Plan Description
See Plan Description
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| Voriconazole | Drug | Specified dose on specified days |
|
| Quinidine | Drug | Specified dose on specified days |
|
| Up to Day 23 |
| Number of participants with vital sign abnormalities | Up to Day 23 |
| Number of participants with electrocardiogram abnormalities | Up to Day 23 |
| Number of participants with clinical safety laboratory test abnormalities | Up to Day 22 |
| Time of maximum observed plasma concentration (Tmax) | Up to Day 23 |
| Apparent terminal phase half-life (T-HALF) | Up to Day 23 |
| Apparent total body clearance (CLT/F) | Up to Day 23 |
| Apparent volume of distribution of terminal phase (Vz/F) | Up to Day 23 |
| Cmax | Up to Day 23 |
| Area under the plasma concentration-time curve over one dosing interval (AUC(TAU)) | Up to Day 23 |
| Trough observed plasma concentration (Ctrough) | Up to Day 23 |
| ID | Term |
|---|---|
| C000708510 | repotrectinib |
| D065819 | Voriconazole |
| D011802 | Quinidine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002930 | Cinchona Alkaloids |
| D000470 | Alkaloids |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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