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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: BMS-986166; Other: Placebo matching BMS-986166

Study type: Interventional

Funder types: Industry

Identifiers

NCT03038711

IM018-003

Details and patient eligibility

About

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

Enrollment: 213 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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213 participants in 3 patient groups

Dose Panel 1

Experimental group

Description:

BMS-986166 or Placebo matching BMS-986166

Treatment:

Other: Placebo matching BMS-986166

Drug: BMS-986166

Dose Panel 2

Experimental group

Description:

BMS-986166 or Placebo matching BMS-986166

Treatment:

Other: Placebo matching BMS-986166

Drug: BMS-986166

Dose Panel 3

Experimental group

Description:

BMS-986166 or Placebo matching BMS-986166

Treatment:

Other: Placebo matching BMS-986166

Drug: BMS-986166