Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02257151
• Collaborator: (none)
• Enrollment: 118
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 10.8

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement of BMS-986142 in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adult	Drug: BMS-986142; Drug: Placebo	Phase 1

Detailed Description

Allocation: Randomized Controlled Trial (SAD/MAD) Masking: Double-Blind (SAD/MAD)

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, and Pharmacokinetics of BMS-986142 in Healthy Subjects
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: BMS-986142 or placebo BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified	Drug: BMS-986142; Drug: Placebo
Experimental: Group 2: BMS-986142 or placebo BMS-986142 or placebo Multiple dose oral Solution as specified	Drug: BMS-986142; Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after single dose of BMS-986142 [Single Ascending Dose(SAD) within 8 days]

2. Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after multiple doses of BMS-986142 [Multiple Ascending Dose (MAD) within 19 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:

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

Exclusion Criteria:

1. Any significant acute or chronic medical illness

2. Current or recent (within 3 months of study drug administration) gastrointestinal disease

3. Any major surgery within 4 weeks of study drug administration

4. Any gastrointestinal surgery that could impact upon the absorption of study drug

5. Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wcct Global, Llc	Cypress	California	United States	90630

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 educational resource

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02257151
• Other Study ID Numbers: IM006-001
• First Posted: Oct 6, 2014
• Last Update Posted: Sep 24, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Bristol-Myers Squibb: Volunteers

Study Results

No Results Posted as of Sep 24, 2015