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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986166
Placebo matching BMS-986166
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • PPD Development, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dose Panel 1

Dose Panel 2

Dose Panel 3

Arm Description

BMS-986166 or Placebo matching BMS-986166

BMS-986166 or Placebo matching BMS-986166

BMS-986166 or Placebo matching BMS-986166

Outcomes

Primary Outcome Measures

Incidence of All Adverse Events (AEs)
measured by number of patients
Incidence of Serious Adverse Events (SAEs)
measured by number of patients
Severity of all Adverse Events (AEs)
measured by investigator
Change from baseline in physical examination findings
measured by investigator
Change from baseline in electrocardiogram (ECG) results
measured by ECG
Change from baseline in continuous cardiac monitoring data
measured with external monitoring device
Change from baseline in clinical laboratory test results
measured by serum chemistry, hematology, serology and urinalysis results
Change from baseline in body temperature
measured in degrees Celsius or Fahrenheit
Change from baseline in respiratory rate
measured by investigator
Change from baseline in seated blood pressure
measured by investigator
Change from baseline in heart rate
measured by investigator

Secondary Outcome Measures

Mean heart rate (HR)
Calculated from nadir HR to time-matched HR on Day -1
Largest decrease in HR from time-matched Day -1 baseline
measured by investigator
Time to nadir HR from time 0 hour (predose)
measured by investigator
Time to largest decrease HR from time 0 hour (predose)
measured by investigator
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
Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline
measured by ALC
Time to largest percent reduction ALC from time 0 hour (predose)
measured by ALC
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
Maximum observed blood concentration (Cmax)
measured by blood concentration versus time data
Time of maximum observed blood concentration (Tmax)
measured by blood concentration versus time data
Terminal half-life (T-HALF)
measured by blood concentration versus time data
Area under the blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
measured by blood concentration versus time data
Area under the blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
measured by blood concentration versus time data
Apparent total clearance (CLT/F)
measured by blood concentration versus time data
Apparent steady state volume (Vz/F)
measured by blood concentration versus time data
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
Maximum observed concentration (Cmax)
Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter

Full Information

First Posted
January 26, 2017
Last Updated
January 28, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03038711
Brief Title
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers
Official Title
A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
August 10, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Panel 1
Arm Type
Experimental
Arm Description
BMS-986166 or Placebo matching BMS-986166
Arm Title
Dose Panel 2
Arm Type
Experimental
Arm Description
BMS-986166 or Placebo matching BMS-986166
Arm Title
Dose Panel 3
Arm Type
Experimental
Arm Description
BMS-986166 or Placebo matching BMS-986166
Intervention Type
Drug
Intervention Name(s)
BMS-986166
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo matching BMS-986166
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Incidence of All Adverse Events (AEs)
Description
measured by number of patients
Time Frame
77 days
Title
Incidence of Serious Adverse Events (SAEs)
Description
measured by number of patients
Time Frame
77 days
Title
Severity of all Adverse Events (AEs)
Description
measured by investigator
Time Frame
77 days
Title
Change from baseline in physical examination findings
Description
measured by investigator
Time Frame
77 days
Title
Change from baseline in electrocardiogram (ECG) results
Description
measured by ECG
Time Frame
77 days
Title
Change from baseline in continuous cardiac monitoring data
Description
measured with external monitoring device
Time Frame
15 days
Title
Change from baseline in clinical laboratory test results
Description
measured by serum chemistry, hematology, serology and urinalysis results
Time Frame
77 days
Title
Change from baseline in body temperature
Description
measured in degrees Celsius or Fahrenheit
Time Frame
77 days
Title
Change from baseline in respiratory rate
Description
measured by investigator
Time Frame
77 days
Title
Change from baseline in seated blood pressure
Description
measured by investigator
Time Frame
77 days
Title
Change from baseline in heart rate
Description
measured by investigator
Time Frame
77 days
Secondary Outcome Measure Information:
Title
Mean heart rate (HR)
Description
Calculated from nadir HR to time-matched HR on Day -1
Time Frame
15 days
Title
Largest decrease in HR from time-matched Day -1 baseline
Description
measured by investigator
Time Frame
15 days
Title
Time to nadir HR from time 0 hour (predose)
Description
measured by investigator
Time Frame
15 days
Title
Time to largest decrease HR from time 0 hour (predose)
Description
measured by investigator
Time Frame
15 days
Title
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
Description
measured by investigator
Time Frame
15 days
Title
Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline
Description
measured by ALC
Time Frame
35 days
Title
Time to largest percent reduction ALC from time 0 hour (predose)
Description
measured by ALC
Time Frame
35 days
Title
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
Description
measured by ALC
Time Frame
77 days
Title
Maximum observed blood concentration (Cmax)
Description
measured by blood concentration versus time data
Time Frame
77 days
Title
Time of maximum observed blood concentration (Tmax)
Description
measured by blood concentration versus time data
Time Frame
77 days
Title
Terminal half-life (T-HALF)
Description
measured by blood concentration versus time data
Time Frame
77 days
Title
Area under the blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Description
measured by blood concentration versus time data
Time Frame
77 days
Title
Area under the blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Description
measured by blood concentration versus time data
Time Frame
77 days
Title
Apparent total clearance (CLT/F)
Description
measured by blood concentration versus time data
Time Frame
77 days
Title
Apparent steady state volume (Vz/F)
Description
measured by blood concentration versus time data
Time Frame
77 days
Title
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Description
Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
Time Frame
77 days
Title
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Description
Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
Time Frame
77 days
Title
Maximum observed concentration (Cmax)
Description
Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
Time Frame
77 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
PPD Development, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32306792
Citation
Singhal S, Girgis IG, Xie J, Dutta S, Shevell DE, Throup J. The safety and pharmacokinetics of a novel, selective S1P1R modulator in healthy participants. Expert Opin Investig Drugs. 2020 Apr;29(4):411-422. doi: 10.1080/13543784.2020.1742322.
Results Reference
derived
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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