Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and pharmacokinetics of BMS-986533 in healthy participants receiving single and multiple doses, to assess food and pH effects on the relative bioavailability of BMS-986533, and the P-gp and BCRP-mediated drug-drug interaction potential of the study drug
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Experimental |
| |
| Arm C | Experimental |
| |
| Arm D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986533 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AE) | Up to Day 47 | |
| Number of participants with Serious Adverse Events (SAE) | Up to Day 47 | |
| Number of participants with Vital Sign Abnormalities | Up to Day 27 | |
| Number of participants with Physical Examination Abnormalities | Including neurological examination | Up to Day 27 |
| Number of participants with Electrocardiogram (ECG) Abnormalities | Up to Day 27 | |
| Number of participants with Clinical Laboratory Assessments Abnormalities | Up to Day 27 | |
| Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Day 27 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to Day 26 from last dose | |
| Time of maximum observed concentration (Tmax) | Up to Day 26 from last dose | |
| Area under the concentration-time curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Lincoln | Nebraska | 68502 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
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.html
See Plan Description
See Plan Description
Not provided
Not provided
Not provided
Not provided
Not provided
| Famotidine | Drug | Specified dose on specified days |
|
| Placebo | Drug | Specified dose on specified days |
|
| Dabigatran Etexilate | Drug | Specified dose on specified days |
|
| Rosuvastatin | Drug | Specified dose on specified days |
|
Arm A, Arm B, and Arm C |
| Up to Day 26 from last dose |
| AUC from Time Zero Extrapolated to Infinite Time (AUC(INF)) | Arm A and Arm C | Up to Day 26 from last dose |
| AUC from Time Zero to 24 Hours (AUC(0-24)) | Arm A | Up to Day 9 from last dose |
| Elimination Half-Life (T-HALF) | Arm A, Arm B, and Arm C | Up to Day 26 from last dose |
| Apparent Total Body Clearance from Plasma (CLT/F) | Arm A, Arm B, and Arm C | Up to Day 26 from last dose |
| Apparent Volume of Distribution (Vz/F) | Arm A, Arm B, and Arm C | Up to Day 26 from last dose |
| AUC in 1 dosing interval (AUC (TAU)) | Arm B, D | Up to Day 22 from last dose |
| Cerebrospinal fluid (CSF) concentrations | Arm B | Up to Day 13 |
| Ratio of total and unbound CSF to plasma concentration | Arm B | Up to Day 13 |
| Geometric mean ratio of Cmax | Arm C, D | Up to Day 26 from last dose |
| Geometric mean ratio of AUC(0-T) | Arm C, D | Up to Day 26 from last dose |
| Geometric mean ratio of AUC(INF) | Arm C, D | Up to Day 26 from last dose |
| Cmax of dabigatran in plasma | Arm D | Up to Day 18 from last dose |
| Cmax of rosuvastatin in plasma | Arm D | Up to Day 20 from last dose |
| AUC(0-T) of dabigatran in plasma | Arm D | Up to Day 18 from last dose |
| AUC(0-T) of rosuvastatin in plasma | Arm D | Up to Day 20 from last dose |
| AUC(INF) of dabigatran in plasma | Arm D | Up to Day 18 from last dose |
| AUC(INF) of rosuvastatin in plasma | Arm D | Up to Day 20 from last dose |
| Tmax of dabigatran in plasma | Arm D | Up to Day 18 from last dose |
| Tmax of rosuvastatin in plasma | Arm D | Up to Day 20 from last dose |
| T-HALF of dabigatran in plasma | Up to Day 26 from last dose |
| T-HALF of rosuvastatin in plasma | Arm D | Up to Day 20 from last dose |
| CLT/F of dabigatran in plasma | Arm D | Up to Day 18 from last dose |
| CLT/F of rosuvastatin in plasma | Up to Day 27 from last dose |
| Vz/F of dabigatran in plasma | Arm D | Up to Day 18 from last dose |
| Vz/F of rosuvastatin in plasma | Arm D | Up to Day 20 from last dose |
| ID | Term |
|---|---|
| D007863 | Lecithin Cholesterol Acyltransferase Deficiency |
| ID | Term |
|---|---|
| D052456 | Hypoalphalipoproteinemias |
| D007009 | Hypolipoproteinemias |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015738 | Famotidine |
| D000069604 | Dabigatran |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D011743 | Pyrimidines |
Not provided
Not provided