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

January 28, 2019 updated by: Bristol-Myers Squibb

A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
213

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • Ppd Development, Llc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Dose Panel 1
BMS-986166 or Placebo matching BMS-986166
Drug: BMS-986166
Specified dose on specified days
Other: Placebo matching BMS-986166
Specified dose on specified days
EXPERIMENTAL: Dose Panel 2
BMS-986166 or Placebo matching BMS-986166
Drug: BMS-986166
Specified dose on specified days
Other: Placebo matching BMS-986166
Specified dose on specified days
EXPERIMENTAL: Dose Panel 3
BMS-986166 or Placebo matching BMS-986166
Drug: BMS-986166
Specified dose on specified days
Other: Placebo matching BMS-986166
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of All Adverse Events (AEs)
Time Frame: 77 days
measured by number of patients
77 days
Incidence of Serious Adverse Events (SAEs)
Time Frame: 77 days
measured by number of patients
77 days
Severity of all Adverse Events (AEs)
Time Frame: 77 days
measured by investigator
77 days
Change from baseline in physical examination findings
Time Frame: 77 days
measured by investigator
77 days
Change from baseline in electrocardiogram (ECG) results
Time Frame: 77 days
measured by ECG
77 days
Change from baseline in continuous cardiac monitoring data
Time Frame: 15 days
measured with external monitoring device
15 days
Change from baseline in clinical laboratory test results
Time Frame: 77 days
measured by serum chemistry, hematology, serology and urinalysis results
77 days
Change from baseline in body temperature
Time Frame: 77 days
measured in degrees Celsius or Fahrenheit
77 days
Change from baseline in respiratory rate
Time Frame: 77 days
measured by investigator
77 days
Change from baseline in seated blood pressure
Time Frame: 77 days
measured by investigator
77 days
Change from baseline in heart rate
Time Frame: 77 days
measured by investigator
77 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean heart rate (HR)
Time Frame: 15 days
Calculated from nadir HR to time-matched HR on Day -1
15 days
Largest decrease in HR from time-matched Day -1 baseline
Time Frame: 15 days
measured by investigator
15 days
Time to nadir HR from time 0 hour (predose)
Time Frame: 15 days
measured by investigator
15 days
Time to largest decrease HR from time 0 hour (predose)
Time Frame: 15 days
measured by investigator
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
Time Frame: 15 days
measured by investigator
15 days
Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline
Time Frame: 35 days
measured by ALC
35 days
Time to largest percent reduction ALC from time 0 hour (predose)
Time Frame: 35 days
measured by ALC
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
Time Frame: 77 days
measured by ALC
77 days
Maximum observed blood concentration (Cmax)
Time Frame: 77 days
measured by blood concentration versus time data
77 days
Time of maximum observed blood concentration (Tmax)
Time Frame: 77 days
measured by blood concentration versus time data
77 days
Terminal half-life (T-HALF)
Time Frame: 77 days
measured by blood concentration versus time data
77 days
Area under the blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time Frame: 77 days
measured by blood concentration versus time data
77 days
Area under the blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time Frame: 77 days
measured by blood concentration versus time data
77 days
Apparent total clearance (CLT/F)
Time Frame: 77 days
measured by blood concentration versus time data
77 days
Apparent steady state volume (Vz/F)
Time Frame: 77 days
measured by blood concentration versus time data
77 days
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time Frame: 77 days
Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
77 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Time Frame: 77 days
Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
77 days
Maximum observed concentration (Cmax)
Time Frame: 77 days
Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
77 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM018-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings