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The purpose of this study is to evaluate the effect of concomitant administration of BMS-986020 on the single dose Pharmacokinetics (PK) of Rosuvastatin in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986020 + Rosuvastatin (Treatment A, B and C) | Experimental | Cohort 1: Rosuvastatin Tablet Single dose and BMS- 986020 orally on specific days Cohort 2 (Administered 4 hrs, after the morning dose of BMS-986020): Rosuvastatin Tablet Single dose and BMS- 986020 orally on specific days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986020 | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of Rosuvastatin with and without coadministered BMS-986020 | 31 timepoints up to Day 12 | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin with and without coadministered BMS-986020 | 31 timepoints up to Day 12 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin with and without coadministered BMS-986020 | 31 timepoints up to Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed plasma concentration (Tmax) of Rosuvastatin with and without coadministered BMS-986020 | 31 timepoints up to Day 12 | |
| Terminal plasma half-life (T-HALF) of Rosuvastatin with and without coadministered BMS-986020 | 31 timepoints up to Day 12 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
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 |
|---|---|---|---|---|---|---|
| Healthcare Discoveries, Llc D/B/A Icon Development Solutions | San Antonio | Texas | 78209 | United States |
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| ID | Term |
|---|---|
| C032881 | lysophosphatidic acid |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Rosuvastatin |
| Drug |
|
|
| Apparent total body clearance (CLT/F) of Rosuvastatin with and without coadministered BMS-986020 | 31 timepoints up to Day 12 |
| Incidence of Adverse Event (AEs), Serious Adverse Event (SAEs), deaths, and AEs leading to discontinuation | Upto Day 12 |
| Results of vital signs, ECGs, Physical Examination (PEs), and clinical lab result | Up to Day 12 |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |