A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers
A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
1 other identifier
interventional
213
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2017
CompletedFirst Posted
Study publicly available on registry
February 1, 2017
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2017
CompletedJanuary 30, 2019
January 1, 2019
6 months
January 26, 2017
January 28, 2019
Conditions
Outcome Measures
Primary Outcomes (11)
Incidence of All Adverse Events (AEs)
measured by number of patients
77 days
Incidence of Serious Adverse Events (SAEs)
measured by number of patients
77 days
Severity of all Adverse Events (AEs)
measured by investigator
77 days
Change from baseline in physical examination findings
measured by investigator
77 days
Change from baseline in electrocardiogram (ECG) results
measured by ECG
77 days
Change from baseline in continuous cardiac monitoring data
measured with external monitoring device
15 days
Change from baseline in clinical laboratory test results
measured by serum chemistry, hematology, serology and urinalysis results
77 days
Change from baseline in body temperature
measured in degrees Celsius or Fahrenheit
77 days
Change from baseline in respiratory rate
measured by investigator
77 days
Change from baseline in seated blood pressure
measured by investigator
77 days
Change from baseline in heart rate
measured by investigator
77 days
Secondary Outcomes (18)
Mean heart rate (HR)
15 days
Largest decrease in HR from time-matched Day -1 baseline
15 days
Time to nadir HR from time 0 hour (predose)
15 days
Time to largest decrease HR from time 0 hour (predose)
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
15 days
- +13 more secondary outcomes
Study Arms (3)
Dose Panel 1
EXPERIMENTALBMS-986166 or Placebo matching BMS-986166
Dose Panel 2
EXPERIMENTALBMS-986166 or Placebo matching BMS-986166
Dose Panel 3
EXPERIMENTALBMS-986166 or Placebo matching BMS-986166
Interventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PPD Development, LLC
Austin, Texas, 78744, United States
Related Publications (1)
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.
PMID: 32306792DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2017
First Posted
February 1, 2017
Study Start
February 1, 2017
Primary Completion
August 10, 2017
Study Completion
August 10, 2017
Last Updated
January 30, 2019
Record last verified: 2019-01