Clinical trial NCT02341638: Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects
Official title: Randomized, Double-Blinded, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-01-19
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.

Detailed description: Maximum Age:

Part A SAD 65 years

Part B MAD 75 years

Part C MAD Japanese 75 years

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

1. Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
2. Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/\[height(m)\]2
3. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive

Exclusion Criteria:

1. Concurrent or use within 2 weeks of study drug administration, of marketed or investigational, drugs as specified in protocol
2. Other protocol-defined exclusion criteria could apply

Primary outcomes:
measure: Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
timeFrame: Up to 30 days post discontinuation of dosing or last participation in the study
measure: Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
timeFrame: Up to 30 days post discontinuation of dosing or last participation in the study
measure: Safety measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
timeFrame: Up to 30 days post discontinuation of dosing or last participation in the study
measure: Tolerability measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
timeFrame: Up to 30 days post discontinuation of dosing or last participation in the study
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
timeFrame: Up to Day 14
measure: Time of maximum observed plasma concentration (Tmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
timeFrame: Up to Day 14
measure: Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
timeFrame: Up to Day 14
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
timeFrame: Up to Day 14
measure: Concentration at 24 hours (C24) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
timeFrame: Up to Day 14
measure: Half-life (T-HALF) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
timeFrame: Up to Day 14
measure: Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
timeFrame: Up to Day 14
measure: AUC accumulation index (AI_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose
timeFrame: Up to Day 14
measure: Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
timeFrame: Up to Day 14
measure: MR_Cmax of BMT-162853, BMT-162856, and BMT-181551
timeFrame: Up to Day 14
measure: MR_AUC(INF) of BMT-162853, BMT-162856, and BMT-181551
timeFrame: Up to Day 14
measure: MR_AUC(0-T) of BMT-162853, BMT-162856, and BMT-181551
timeFrame: Up to Day 14
measure: MR_AUC(TAU) of BMT-162853, BMT-162856, and BMT-181551
timeFrame: Up to Day 14
measure: Safety of multiple doses of BMS-986141 and aspirin in healthy subjects
timeFrame: Up to 30 days post discontinuation of dosing or last participation in the study
measure: Tolerability of multiple doses of BMS-986141 and aspirin in healthy subjects
timeFrame: Up to 30 days post discontinuation of dosing or last participation in the study
measure: Safety of BMS-986141 and itraconazole in healthy subjects
timeFrame: Up to 30 days post discontinuation of dosing or last participation in the study
measure: Tolerability of BMS-986141 and itraconazole in healthy subjects
timeFrame: Up to 30 days post discontinuation of dosing or last participation in the study
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials, Llc
state: California
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: