Clinical trial NCT03197779: A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS- 962212 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-23
Enrollment: 691
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics following increasing doses of 2 h (Part A) and 5 day (Part B) continuous IV infusions of BMS-962212 in healthy subjects across the expected pharmacodynamic dose range.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive \[as calculated by BMI = weight (kg)/ \[height (m)\]2
* This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, subject has not been randomized / has not been treated). If re-enrolled, the subject must be re-consented
* Men, ages 18 to 45 years, inclusive; women, ages 18-45, who are not of child-bearing potential
* Women must not be breastfeeding

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Women of child-bearing potential
* Current or recent (within 3 months of study drug administration) gastrointestinal disease which by the judgment of the Investigator may increase a subject's risk of gastrointestinal bleeding (e.g., peptic or gastric ulcer disease, severe gastritis, history of gastrectomy)
* Any major surgery within 12 weeks of study drug administration
* History of blood transfusion, clinically significant bleeding event(s), or documented genetic bleeding diathesis or thrombophilia
* For Aspirin Containing Arm Participants Only: Known allergy to non-steroidal anti-inflammatory drugs or history of intolerance or abnormal sensitivity to aspirin (e.g gastrointestinal intolerance, bruising or bleeding, aspirin induced breathing difficulties or nasal polyps)

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Adverse Events (AE)
timeFrame: Up to 8 days
measure: Serious Adverse Events (SAE)
timeFrame: Up to 8 days
measure: Discontinuation due to AE
timeFrame: Up to 8 days
measure: Death
timeFrame: Up to 8 days
measure: AE of clinically significant bleeding
timeFrame: Up to 8 days
measure: AE of clinically significant infusion reaction
timeFrame: Up to 8 days
measure: AE of clinically significant vital signs
timeFrame: Up to 8 days
measure: QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula
timeFrame: Up to 8 days
measure: QRS - The interval from the beginning of the Q wave and the end of the S wave
timeFrame: Up to 8 days
measure: PR - The interval from the beginning of the P wave to the beginning of the QRS complex
timeFrame: Up to 8 days
measure: 24-hour cardiac monitoring
timeFrame: Up to 6 days
measure: Glomerular filtration rate (GFR)
timeFrame: Up to 8 days
measure: Cystatin-C
timeFrame: Up to 8 days
measure: Neutrophil gelatinase-associated lipocalin (NGAL)
timeFrame: Up to 8 days
measure: Monocyte chemoattractant protein-1 (MCP-1)
timeFrame: Up to 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Wcct Global, Llc
state: California
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
city: Baltimore
country: United States
facility: Parexel International - Baltimore Epcu
state: Maryland
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: