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The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole | Drug | Specified dose on specified days. |
| |
| Rifampin |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 67 | |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) | Up to Day 67 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 67 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to Day 69 | |
| Number of participants with physical exam abnormalities | Up to Day 69 | |
| Number of participants with vital sign 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 |
|---|---|---|---|---|---|---|
| Local Institution - 0002 | Atlanta | Georgia | 30331 | United States | ||
| Local Institution - 0001 |
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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/disclosure-commitment.html
See plan description
See plan description
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| Drug |
Specified dose on specified days |
|
| Golcadomide | Drug | Specified dose on specified days |
|
|
| Up to Day 69 |
| Number of participants with clinical laboratory safety test abnormalities | Up to Day 69 |
| Number of participants with electrocardiogram abnormalities | Up to Day 69 |
| Number of participants with concomitant medications | Up to Day 69 |
| Number of participants with concomitant procedures | Up to Day 69 |
| Time of maximum observed plasma concentration (Tmax) | Up to Day 67 |
| Apparent terminal phase half-life (T-HALF) | Up to Day 67 |
| Apparent total body clearance (CLT/F) | Up to Day 67 |
| Apparent volume of distribution (Vz/F) | Up to Day 67 |
| Lenexa |
| Kansas |
| 66219 |
| United States |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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