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

NCT ID: NCT02211469

Last Updated: 2015-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-07-31

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Panel 1: BMS-986104 or Placebo

BMS-986104 or Placebo single dose by mouth as specified

Group Type: EXPERIMENTAL

BMS-986104

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Panel 2: BMS-986104 or Placebo

BMS-986104 or Placebo single dose by mouth as specified

Group Type: EXPERIMENTAL

BMS-986104

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Panel 3: BMS-986104 or Placebo

BMS-986104 or Placebo single dose by mouth as specified

Group Type: EXPERIMENTAL

BMS-986104

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Panel 4: BMS-986104 or Placebo

BMS-986104 or Placebo single dose by mouth as specified

Group Type: EXPERIMENTAL

BMS-986104

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

BMS-986104

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, United States

Countries

United States

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

IM001-001

Identifier Type: -

Identifier Source: org_study_id