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

Phase 1

Completed

• Conditions: Severe Sepsis
• Interventions: Other: Placebo; Drug: BMS-986189

• Registration Number: NCT02739373
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-08
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-15
• Study Start: 2016-04-18
• Primary Completion: 2016-12-14
• Study Completion: 2016-12-14
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Specified Dose on Specified Day
BMS-986189	BMS-986189	Specified Dose on Specified Day

Primary Outcome Measures

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

Trial Locations

Locations (1)

Covance Clinical Research Unit, Inc.; 🇺🇸 Evansville, Indiana, United States