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Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.
A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability data to be collected and assessed as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhibition (Cohort 1) | Experimental | Single oral dose BMS-986205 |
|
| Inhibition (Cohort 2) | Experimental | Daily oral itraconazole doses for 24 days; single oral dose BMS-986205 on day 4 |
|
| Induction (Cohort 3) | Experimental | Single oral dose BMS-986205 |
|
| Induction (Cohort 4) | Experimental | Daily oral rifampin doses for21 days; single oral dose BMS-986205 on day 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986205 | Drug | BMS-986205 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Measured by plasma concentration | Up to 25 days |
| AUC from time zero to time of last quantifiable concentration (AUC(0-T)) | Measured by plasma concentration | Up to 25 days |
| AUC from time zero extrapolated to infinite time (AUC(INF)) | Measured by plasma concentration | Up to 25 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Safety and tolerability as measured by incidence of AEs | Up to 25 days |
| Incidence of Serious Adverse Events (SAEs) | Safety and tolerability as measured by incidence of SAEs |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion / exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Briston-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| C000630574 | linrodostat |
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Oral solution |
|
| Rifampin | Drug | Tablet |
|
| Up to 76 days |
| Number of participants with electrocardiogram abnormalities | Up to 25 days |
| Number of participants with physical examination findings abnormalities | Up to 25 days |
| Number of participants with clinical laboratory abnormalities | Up to 25 days |
| 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 |