Clinical trial NCT04154800: A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants
Official title: A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986209 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Health Participants
Keywords: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-11-07
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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/exclusion criteria apply

Primary outcomes:
measure: Incidence of Adverse Events (AEs) including bleeding
timeFrame: Up to 18 days
measure: Incidence of serious AEs (SAEs)
timeFrame: Up to 44 days
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 18 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 18 days
measure: Incidence of clinically significant changes in vital signs: Respiratory Rate
timeFrame: Up to 18 days
measure: Incidence of clinically significant changes in vital signs: Seated blood pressure
timeFrame: Up to 18 days
measure: Incidence of clinically significant changes in vital signs: Resting pulse rate
timeFrame: Up to 18 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters
timeFrame: Up to 18 days
measure: Incidence of clinically significant changes in clinical laboratory tests: Hematology tests
timeFrame: Up to 16 days
measure: Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests
timeFrame: Up to 16 days
measure: Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests
timeFrame: Up to 16 days
measure: Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests
timeFrame: Up to 16 days
measure: Incidence of clinically significant changes in clinical laboratory tests: Serology tests
timeFrame: Up to 16 days
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986209
timeFrame: Up to 18 days
measure: Time of Maximum observed plasma concentration (Tmax) of BMS-986209
timeFrame: Up to 18 days
measure: Terminal plasma half-life (T-Half) of BMS-986209
timeFrame: Up to 18 days
measure: Incidence of Adverse Events (AEs) including bleeding
timeFrame: Up to 18 days
measure: Incidence of serious AEs (SAEs)
timeFrame: Up to 44 days
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 18 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 18 days
measure: Incidence of clinically significant changes in vital signs: Respiratory Rate
timeFrame: Up to 18 days
measure: Incidence of clinically significant changes in vital signs: Seated blood pressure
timeFrame: Up to 18 days
measure: Incidence of clinically significant changes in vital signs: Resting pulse rate
timeFrame: Up to 18 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters
timeFrame: Up to 18 days
measure: Incidence of clinically significant changes in clinical laboratory tests: Hematology tests
timeFrame: Up to 16 days
measure: Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests
timeFrame: Up to 16 days
measure: Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests
timeFrame: Up to 16 days
measure: Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests
timeFrame: Up to 16 days
measure: Incidence of clinically significant changes in clinical laboratory tests: Serology tests
timeFrame: Up to 16 days
measure: Percent change from baseline in plasma activated partial thromboplastin time (aPTT) levels
timeFrame: Up to 16 days
measure: Percent change from baseline in factor XI (FXI) clotting activity
timeFrame: Up to 16 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: