A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety and tolerability of BMS-986209 in healthy participants. The first-in-human study is designed in 3 parts that vary based on duration and food effect.

Official Title
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A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986209 in Healthy Participants

Conditions
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Health Participants

Intervention / Treatment
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* Drug: BMS-986209
* Other: BMS-986209 Placebo
* Drug: Itraconazole
* Drug: Diltiazem


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Healthy male and female participants (not of childbearing potential) as determined by no deviation considered significant by the investigator from normal in medical history, physical examination, 12-lead ECG measurements, and clinical laboratory determinations Women and men must agree to follow specific methods of contraception if applicable. Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants Exclusion Criteria: Women who are of childbearing potential Women who are breastfeeding Any acute or chronic medical illness History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study treatment administration) History of heart disease or conduction disorders Head injury in the last 2 years, intracranial tumor, or aneurysm Known abdominal aneurysm Current or history of rectal bleeding, hematemesis, or hematuria Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A:SAD<br>Single Ascending Dose | Drug: BMS-986209<br>* Specified Dose on Specified Days<br>|
| Experimental: Part B: MAD<br>Multiple Ascending Dose | Drug: BMS-986209<br>* Specified Dose on Specified Days<br>|
| Experimental: Part C: DDI<br>Drug-Drug Interaction | Drug: BMS-986209<br>* Specified Dose on Specified Days<br>Drug: Itraconazole<br>* Specified Dose on Specified Days<br>Drug: Diltiazem<br>* Specified Dose on Specified Days<br>|
| Experimental: Part A (SAD) Placebo<br> | Other: BMS-986209 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part B (MAD) Placebo<br> | Other: BMS-986209 Placebo<br>* Specified Dose on Specified Days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) including bleeding |  | Up to 18 days | 
| Incidence of serious AEs (SAEs) |  | Up to 44 days | 
| Incidence of AEs leading to discontinuation |  | Up to 18 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 18 days | 
| Incidence of clinically significant changes in vital signs: Respiratory Rate |  | Up to 18 days | 
| Incidence of clinically significant changes in vital signs: Seated blood pressure |  | Up to 18 days | 
| Incidence of clinically significant changes in vital signs: Resting pulse rate |  | Up to 18 days | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters |  | Up to 18 days | 
| Incidence of clinically significant changes in clinical laboratory tests: Hematology tests |  | Up to 16 days | 
| Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests |  | Up to 16 days | 
| Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests |  | Up to 16 days | 
| Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests |  | Up to 16 days | 
| Incidence of clinically significant changes in clinical laboratory tests: Serology tests |  | Up to 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of BMS-986209 |  | Up to 18 days | 
| Time of Maximum observed plasma concentration (Tmax) of BMS-986209 |  | Up to 18 days | 
| Terminal plasma half-life (T-Half) of BMS-986209 |  | Up to 18 days | 
| Incidence of Adverse Events (AEs) including bleeding |  | Up to 18 days | 
| Incidence of serious AEs (SAEs) |  | Up to 44 days | 
| Incidence of AEs leading to discontinuation |  | Up to 18 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 18 days | 
| Incidence of clinically significant changes in vital signs: Respiratory Rate |  | Up to 18 days | 
| Incidence of clinically significant changes in vital signs: Seated blood pressure |  | Up to 18 days | 
| Incidence of clinically significant changes in vital signs: Resting pulse rate |  | Up to 18 days | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters |  | Up to 18 days | 
| Incidence of clinically significant changes in clinical laboratory tests: Hematology tests |  | Up to 16 days | 
| Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests |  | Up to 16 days | 
| Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests |  | Up to 16 days | 
| Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests |  | Up to 16 days | 
| Incidence of clinically significant changes in clinical laboratory tests: Serology tests |  | Up to 16 days | 
| Percent change from baseline in plasma activated partial thromboplastin time (aPTT) levels |  | Up to 16 days | 
| Percent change from baseline in factor XI (FXI) clotting activity |  | Up to 16 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Participants