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NCT02739373 Clinical Trial

Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects

Severe Sepsis Clinical Trial

Official title:
Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02739373
Other study ID # AI006-003
Secondary ID
Status Completed
Phase Phase 1
First received April 8, 2016
Last updated February 5, 2018
Start date April 18, 2016
Est. completion date December 14, 2016

Study information
Verified date February 2018
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to measure the amount of study drug (BMS-986189) in the blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after a single dose.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date December 14, 2016
Est. primary completion date December 14, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

- Healthy, males and females, 18 to 55 years of age, inclusive

- Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive

- Women of childbearing potential (WOCBP) must have negative serum pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to start of study drug

Exclusion Criteria:

- Any significant acute or chronic medical illness

- History of diabetes mellitus, severe hypertriglyceridemia, acute or chronic pancreatitis, pancreatic exocrine disorder

- History of autoimmune disease

- Any known skin condition that would affect subcutaneous dosing

- Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV -1 and HIV -2 antibody

Other protocol defined inclusion/exclusion criteria could apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• BMS-986189

Other:
• Placebo

Locations
Country Name City State
United States Covance Clinical Research Unit, Inc. Evansville Indiana

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 Maximum observed concentration (Cmax) Day 1 to Day 30
Primary Time of maximum observed concentration (Tmax) Day 1 to Day 30
Primary Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(O-T)) Day 1 to Day 30
Primary Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Day 1 to Day 30
Primary Half Life (T-HALF) Day 1 to Day 30
Primary Total Body Clearance (CLT/F) Day 1 to Day 30
Primary Apparent volume of distribution at steady state (Vss/F) Day 1 to Day 30
Primary Deaths leading to discontinuation Day 1 to Day 30
Primary Adverse events (AEs) leading to discontinuation Day 1 to Day 30
Primary Serious adverse events (SAEs) leading to discontinuation Day 1 to Day 30
Primary Lab abnormalities leading to discontinuation Day 1 to Day 30
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