Safety and Tolerability Study of BMS-986177 in Healthy Subjects

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02608970
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.7
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy subjects

Condition or Disease	Intervention/Treatment	Phase
Thrombosis	Drug: BMS-986177; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BMS-986177 in Healthy Subjects
• Actual Study Start Date: Dec 31, 2015
• Actual Primary Completion Date: Jul 23, 2017
• Actual Study Completion Date: Jul 23, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986177 BMS-986177 specified dose on specified days	Drug: BMS-986177
Other: Placebo Placebo specified dose on specified days	Other: Placebo

Outcome Measures

Primary Outcome Measures

1. Safety of single dose of BMS-986177 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 [Approximately 3 days]

   Adverse event (AE), Serious adverse event (SAE)

2. Safety of multiple dose of BMS-986177 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 [Approximately 16 days]

3. Tolerability of single dose of BMS-986177 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 [Approximately 3 days]

4. Tolerability of multiple dose of BMS-986177 measured by number of subjects who experience SAE, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations [Approximately 16 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

For more information regarding BMS 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, ECGs and clinical laboratory determinations

• Body Mass Index (BMI) of 18 to 30 kg/m2 inclusive. BMI = weight (kg)/ [height (m)]2

• Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 55, inclusive

Exclusion Criteria:

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population

• Any condition that could affect drug absorption

• Other protocol-defined exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SGS Belgium NV	Antwerpen		Belgium	2060

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Patient Recruiting
• BMS clinical trial educational resource

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02608970
• Other Study ID Numbers: CV010-001; 2015-003065-29
• First Posted: Nov 20, 2015
• Last Update Posted: Jul 31, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Thrombosis

Study Results

No Results Posted as of Jul 31, 2017