A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers

Bristol-Myers Squibb213 enrolled

Overview

The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and well tolerated in healthy patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Enrollment

213

Conditions

Ulcerative Colitis

Interventions

BMS-986166DRUG

Specified dose on specified days

Placebo matching BMS-986166OTHER

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy female patients of non-childbearing potential or male patients as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study * Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive * This study permits the re-enrollment of a patient that has discontinued the study as a pre-treatment failure (i.e. patient has not been randomized / has not been treated). If re-enrolled, the patient must be re-consented Exclusion Criteria: * Women who are of childbearing potential, lactating or breastfeeding * Any significant acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor * Patients with history of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease * Patients with any acute or chronic bacterial, fungal (except history of tinea pedis or ongoing onychomycosis will not be exclusionary) or viral infection within the last 3 months prior to screening, as well as any febrile illness or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening * Patients who have received any live vaccines within 1 month of study drug administration, or who plan to have a live vaccine at any time during the study, including during the follow up period * Positive test for tuberculosis at screening * Past or current history of neurologic disorders, Guillain-Barré Syndrome, central or peripheral neuropathies, or past or current symptoms of sustained or recurrent paresthesia's (tingling), numbness, or neuropathic pain (burning, aching or stabbing) in any extremities Other protocol defined inclusion/exclusion criteria could apply

Locations (1)

PPD Development, LLC

Austin, Texas, United States

Outcomes

Primary Outcomes

Incidence of All Adverse Events (AEs)

measured by number of patients

Time frame: 77 days

Incidence of Serious Adverse Events (SAEs)

measured by number of patients

Time frame: 77 days

Severity of all Adverse Events (AEs)

measured by investigator

Time frame: 77 days

Change from baseline in physical examination findings

measured by investigator

Time frame: 77 days

Change from baseline in electrocardiogram (ECG) results

measured by ECG

Time frame: 77 days

Change from baseline in continuous cardiac monitoring data

measured with external monitoring device

Time frame: 15 days

Change from baseline in clinical laboratory test results

measured by serum chemistry, hematology, serology and urinalysis results

Time frame: 77 days

Change from baseline in body temperature

measured in degrees Celsius or Fahrenheit

Time frame: 77 days

Change from baseline in respiratory rate

measured by investigator

Time frame: 77 days

Change from baseline in seated blood pressure

Data from ClinicalTrials.gov

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Secondary Outcomes

Mean heart rate (HR)

Calculated from nadir HR to time-matched HR on Day -1

Time frame: 15 days

Largest decrease in HR from time-matched Day -1 baseline

measured by investigator

Time frame: 15 days

Time to nadir HR from time 0 hour (predose)

measured by investigator

Time frame: 15 days

Time to largest decrease HR from time 0 hour (predose)

measured by investigator

Time frame: 15 days

Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 HR value

measured by investigator

Time frame: 15 days

Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline

measured by ALC

Time frame: 35 days

Time to largest percent reduction ALC from time 0 hour (predose)

measured by ALC

Time frame: 35 days

Mean percent change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 ALC value

measured by ALC

Time frame: 77 days

Maximum observed blood concentration (Cmax)