A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants
Phase 1
Completed
- Conditions
- Health Participants
- Interventions
- Registration Number
- NCT04154800
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part C: DDI BMS-986209 Drug-Drug Interaction Part C: DDI Itraconazole Drug-Drug Interaction Part B: MAD BMS-986209 Multiple Ascending Dose Part A (SAD) Placebo BMS-986209 Placebo - Part B (MAD) Placebo BMS-986209 Placebo - Part A:SAD BMS-986209 Single Ascending Dose Part C: DDI Diltiazem Drug-Drug Interaction
- Primary Outcome Measures
Name Time Method Incidence of AEs leading to discontinuation Up to 18 days Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests Up to 16 days Incidence of clinically significant changes in vital signs: Body temperature 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: Urinalysis tests Up to 16 days Incidence of serious AEs (SAEs) Up to 44 days Incidence of clinically significant changes in vital signs: Respiratory Rate Up to 18 days Incidence of clinically significant changes in vital signs: Resting pulse rate Up to 18 days Incidence of Adverse Events (AEs) including bleeding 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 clinical laboratory tests: Hematology 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: Serology tests Up to 16 days
- Secondary Outcome Measures
Name Time Method Incidence of clinically significant changes in electrocardiogram (ECG) parameters Up to 18 days Incidence of clinically significant changes in vital signs: Respiratory Rate Up to 18 days Percent change from baseline in factor XI (FXI) clotting activity Up to 16 days Incidence of Adverse Events (AEs) including bleeding Up to 18 days Incidence of clinically significant changes in vital signs: Seated blood pressure Up to 18 days Maximum observed plasma concentration (Cmax) of BMS-986209 Up to 18 days Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests Up to 16 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: Resting pulse rate Up to 18 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: Serology tests Up to 16 days Percent change from baseline in plasma activated partial thromboplastin time (aPTT) levels Up to 16 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 clinically significant changes in clinical laboratory tests: Hematology tests Up to 16 days Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests Up to 16 days
Trial Locations
- Locations (1)
PPD Development, LP
🇺🇸Austin, Texas, United States