A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: BMS-986104; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02211469

IM001-001

Details and patient eligibility

About

The primary objective in this study is to assess if single doses of BMS-986104 that are safe, tolerable, and result in sufficient lymphopenia (50% to 70% reduction in absolute lymphocyte count) can be achieved without bradycardia or other adverse events in healthy male subjects.

Enrollment: 41 patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Healthy male subjects 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
• Men ages 18 to 49 years, inclusive

Exclusion Criteria:

• Any acute or chronic medical illness judged to be clinically-significant by the Investigator and/or Sponsor medical monitor
• Presence of fecal occult blood at screening
• History of prolonged occupational exposure to organic solvents or pesticides
• History of vitamin B12 deficiency and/or achlorhydria; or a vitamin B12 level at screening <lower limit of normal (LLN), confirmed by repeat test
• History of Guillain-Barré Syndrome
• Past or current history of central or peripheral neuropathies, or past or current symptoms of sustained or recurrent paresthesias (tingling), numbness, or neuropathic pain (burning, aching or stabbing) in any extremities. Note: Experiencing an extremity "falling asleep" occasionally is not be exclusionary
• Clinically significant abnormality in the neurological exam at baseline (predose)
• Clinically significant nerve electrophysiology abnormalities at baseline (predose)
• Any history of testicular or epididymal disease/disorder
• Clinically significant abnormality on ophthalmologic exam or any findings suggesting an increased risk of macular edema at baseline (predose)
• History of hypothyroidism or carpal tunnel syndrome
• Subjects with history of diabetes mellitus
• Subjects with history of any type of heart disease, including ischemia, infarction, arrhythmias, hypertension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease
• Subjects with any acute or chronic bacterial, fungal 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
• Subjects 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
• Positive test for tuberculosis at screening (QuantiFERON® GOLD)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 4 patient groups

Panel 1: BMS-986104 or Placebo

Experimental group

Description:

BMS-986104 or Placebo single dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986104

Panel 2: BMS-986104 or Placebo

Experimental group

Description:

BMS-986104 or Placebo single dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986104

Panel 3: BMS-986104 or Placebo

Experimental group

Description:

BMS-986104 or Placebo single dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986104

Panel 4: BMS-986104 or Placebo

Experimental group

Description:

BMS-986104 or Placebo single dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986104