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NCT02257151 Clinical Trial

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

Healthy Adult Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02257151
Other study ID # IM006-001
Secondary ID
Status Completed
Phase Phase 1
First received October 2, 2014
Last updated September 22, 2015
Start date September 2014
Est. completion date August 2015

Study information
Verified date September 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 118
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 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

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• BMS-986142

• Placebo

Locations
Country Name City State
United States Wcct Global, 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 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 Yes
Primary 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 Yes
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