Thrombosis
Conditions
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
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 30 days post discontinuation of dosing or last participation in the study | Serious adverse event (SAE) Adverse event (AE) Electrocardiogram (ECG) |
| 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 | Up to 30 days post discontinuation of dosing or last participation in the study | — |
| 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 | Up to 30 days post discontinuation of dosing or last participation in the study | — |
| 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 | Up to 30 days post discontinuation of dosing or last participation in the study | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration at 24 hours (C24) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 | — |
| Half-life (T-HALF) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 | — |
| Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 | — |
| 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 | Up to Day 14 | — |
| 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 | Up to Day 14 | — |
| MR_Cmax of BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 | Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR\_Cmax) |
| Maximum observed plasma concentration (Cmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 | — |
| MR_AUC(0-T) of BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 | Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight \[MR\_AUC(0-T)\] |
| MR_AUC(TAU) of BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 | Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight \[MR\_AUC(TAU)\] |
| Safety of multiple doses of BMS-986141 and aspirin in healthy subjects | Up to 30 days post discontinuation of dosing or last participation in the study | 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. |
| Tolerability of multiple doses of BMS-986141 and aspirin in healthy subjects | Up to 30 days post discontinuation of dosing or last participation in the study | 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 |
| Safety of BMS-986141 and itraconazole in healthy subjects | Up to 30 days post discontinuation of dosing or last participation in the study | 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 |
| Tolerability of BMS-986141 and itraconazole in healthy subjects | Up to 30 days post discontinuation of dosing or last participation in the study | 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 |
| MR_AUC(INF) of BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 | Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight \[MR\_AUC(INF)\] |
| Time of maximum observed plasma concentration (Tmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 | — |
| 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 | Up to Day 14 | — |
| 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 | Up to Day 14 | — |
Countries
United States
Outcome results
None listed