Health Participants
Conditions
Keywords
Healthy Participants
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.
Interventions
DRUGBMS-986209
Specified Dose on Specified Days
OTHERBMS-986209 Placebo
Specified Dose on Specified Days
DRUGItraconazole
Specified Dose on Specified Days
DRUGDiltiazem
Specified Dose on Specified Days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Parts A,B,(Participant, Care Provider, Investigator) Part C is open-labeled and a cross- over design
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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/
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Maximum observed plasma concentration (Cmax) of BMS-986209 | Up to 18 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 |
| Incidence of clinically significant changes in clinical laboratory tests: Serology tests | 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 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 |
Countries
United States
Outcome results
None listed