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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02739373

Enrollment

Registered

2016-04-15

Start date

2016-04-18

Completion date

2016-12-14

Last updated

2018-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Sepsis

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.

Interventions

DRUGBMS-986189

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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/

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026