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
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 49 |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | July 2015 |
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.
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.
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
- 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)
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