A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers
NCT ID: NCT03038711
Last Updated: 2019-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
213 participants
INTERVENTIONAL
2017-02-01
2017-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Dose Panel 1
BMS-986166 or Placebo matching BMS-986166
BMS-986166
Specified dose on specified days
Placebo matching BMS-986166
Specified dose on specified days
Dose Panel 2
BMS-986166 or Placebo matching BMS-986166
BMS-986166
Specified dose on specified days
Placebo matching BMS-986166
Specified dose on specified days
Dose Panel 3
BMS-986166 or Placebo matching BMS-986166
BMS-986166
Specified dose on specified days
Placebo matching BMS-986166
Specified dose on specified days
Interventions
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BMS-986166
Specified dose on specified days
Placebo matching BMS-986166
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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PPD Development, LLC
Austin, Texas, United States
Countries
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References
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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.
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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IM018-003
Identifier Type: -
Identifier Source: org_study_id
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