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A Randomized double blind, placebo controlled study of BMS-986259 to evaluate the safety and effectiveness of the drug amongst different conditions and populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A SAD - A1 Cohort | Experimental | Single Ascending Dose |
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| Part A SAD - A2 Cohort | Experimental | Single Ascending dose |
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| Part A SAD- A3 Cohort | Experimental | Single Ascending dose |
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| Part A SAD- A4 Cohort | Experimental | Single Ascending dose |
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| Part A SAD - A5 Cohort | Experimental | Single Ascending dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986259 | Drug | Single and Multiple ascending dose from Dose 1 to Dose 5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 7 weeks | |
| Incidence of Serious Adverse Events (SAEs) | up to 7 weeks | |
| AEs leading to discontinuation | Up to 7 weeks | |
| Number of clinically significant changes in vital signs | Up to 7 weeks | |
| Number of clinically significant changes in ECG (electrocardiogram) | Up to 7 weeks | |
| Number of clinically significant changes in physical examinations | Up to 7 weeks | |
| Number of clinically significant changes in clinical laboratory tests | Up to 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration(Cmax)- Part A SAD | up to 7 weeks | |
| Time of maximum observed concentration(Tmax)- Part A SAD | Up to 7 weeks | |
| Terminal elimination rate constant (Lz)-Part A SAD |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences - Groningen | Groningen | 9728 NZ | Netherlands | |||
| Richmond Pharmacology |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Part A SAD- A6 Cohort | Experimental | Single Ascending dose |
|
| Part B MAD- B1 Cohort | Experimental | Multiple Ascending Dose |
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| Part B MAD - B2 Cohort | Experimental | Multiple Ascending Dose |
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| Part B MAD - B3 Cohort | Experimental | Multiple Ascending Dose |
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| Part B MAD - B4 Cohort | Experimental | Multiple Ascending Dose |
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| Part C JMAD - C1 Cohort | Experimental | Japanese Multiple Ascending Dose |
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| Part C JMAD - C2 Cohort | Experimental | Japanese Multiple Ascending Dose |
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| Part C JMAD - C3 Cohort | Experimental | Japanese Multiple Ascending Dose |
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| Placebo | Other | Placebo matching BMS-986259 |
|
| P-Aminohippurate | Diagnostic Test | Diagnostic Agent |
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| Iohexol | Diagnostic Test | Diagnostic Agent |
|
| up to 7 weeks |
| Half life (T-HALF)- Part A SAD | Up to 7 weeks |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)- Part A SAD | Up to 7 weeks |
| Area under the concentration-time curve from time zero extrapolated to infinite time(AUC(INF)-Part A SAD | Up to 7 weeks |
| Apparent total body clearance(CL/F)-Part A SAD | Up to 7 weeks |
| Apparent volume of distribution at terminal phase(Vz/F)- Part A SAD | Up to 7 weeks |
| Maximum observed concentration(Cmax)-Part B and Part C MAD | For day 1 , day 13 and day 14 | Up to 7 years |
| Time of maximum observed concentration(Tmax)-Part B and Part C MAD | For day 1, day 13 and day 14 | Up tp 7 weeks |
| Area under the concentration-time curve in one dosing interval(AUC(TAU)- Part B and Part C MAD | For day 1 and day 14 | Up to 7 weeks |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)-Part B and Part C MAD | For Day 14 | Up to 7 weeks |
| Terminal elimination rate constant (Lz)-Part B and Part C MAD | For day 14 | up to 7 weeks |
| Half life (T-HALF)- Part B and Part C MAD | For day 14 | Up to 7 weeks |
| Apparent total body clearance(CL/F)-Part B and Part C MAD | For day 14 | Up to 7 weeks |
| Apparent volume of distribution at terminal phase(Vz/F)- Part B and Part C MAD | For day 14 | Up to 7 weeks |
| Accumulation Ratio Cmax (AR(Cmax)-Part B and Part C MAD | For day 14 | Up to 7 weeks |
| Accumulation Ratio AUC(TAU) (AR(AUC[TAU])- Part B and Part C MAD | for day 14 | Up to 7 weeks |
| London |
| SE1 1YR |
| United Kingdom |
| FDA Safety Alerts and Recalls | View source |