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

Completed · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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

Key facts

Study ID

NCT03038711

Run by

Bristol-Myers Squibb

People needed

213

Starts

2017-02-01

Expected to finish

2017-08-10

Last updated by the study team

2019-01-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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 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

Where it is running

• PPD Development, LLC — Austin, Texas, United States

Full record on ClinicalTrials.gov

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