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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-18

Study Completion Date

2016-12-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Severe Sepsis

NCT02576457

Severe Sepsis Septic Shock

TERMINATED PHASE1

Study of Multiple-dose Kukoamine B Mesilate in Sepsis Patients

NCT03237728

Sepsis

COMPLETED PHASE1

Methylene Blue in Severe Sepsis and Septic Shock

NCT01797978

Severe Sepsis Septic Shock

UNKNOWN PHASE3

A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.

NCT02960854

Severe Sepsis

COMPLETED PHASE1

Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients

NCT04803955

Sepsis

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BMS-986189

Specified Dose on Specified Day

Group Type EXPERIMENTAL

BMS-986189

Intervention Type DRUG

Placebo

Specified Dose on Specified Day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-986189

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes