Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects

Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341638
• Other study ID #: CV006-003
• Status: Completed
• Phase: Phase 1
• First received: January 14, 2015
• Last updated: March 29, 2017
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Maximum Age:

Part A SAD 65 years

Part B MAD 75 years

Part C MAD Japanese 75 years

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• BMS-986141

• Placebo

• Aspirin

• Itraconazole

Locations

Country	Name	City	State
United States	Ppd Development, Lp	Austin	Texas
United States	West Coast Clinical Trials, Llc	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serious adverse event (SAE); Adverse event (AE); Electrocardiogram (ECG)	Up to 30 days post discontinuation of dosing or last participation in the study
Primary	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
Primary	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
Primary	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	Maximum observed plasma concentration (Cmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551		Up to Day 14
Secondary	Time of maximum observed plasma concentration (Tmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551		Up to Day 14
Secondary	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
Secondary	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
Secondary	Concentration at 24 hours (C24) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551		Up to Day 14
Secondary	Half-life (T-HALF) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551		Up to Day 14
Secondary	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
Secondary	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
Secondary	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
Secondary	MR_Cmax of BMT-162853, BMT-162856, and BMT-181551	Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax)	Up to Day 14
Secondary	MR_AUC(INF) of BMT-162853, BMT-162856, and BMT-181551	Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight [MR_AUC(INF)]	Up to Day 14
Secondary	MR_AUC(0-T) of BMT-162853, BMT-162856, and BMT-181551	Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight [MR_AUC(0-T)]	Up to Day 14
Secondary	MR_AUC(TAU) of BMT-162853, BMT-162856, and BMT-181551	Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)]	Up to Day 14
Secondary	Safety of multiple doses of BMS-986141 and aspirin in healthy subjects	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
Secondary	Tolerability of multiple doses of BMS-986141 and aspirin in healthy subjects	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
Secondary	Safety of BMS-986141 and itraconazole in healthy subjects	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
Secondary	Tolerability of BMS-986141 and itraconazole in healthy subjects	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

External Links

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