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

NCT02211469 | Completed Phase 1

• 1 other identifier: IM001-001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Incidence of all adverse events (AEs) / serious adverse events (SAEs)

  Up to 1 month post discharge

• Mean difference in ECG heart rate (HR) nadir values

  Up to 4 days postdose

• Nadir absolute lymphocyte count (ALC) defined as the lowest ALC measured at any time after the dose

  Up to 4 days postdose

Secondary Outcomes (13)

• Safety and tolerability based on severity, investigator causality assessment and outcomes of all AEs (regardless of seriousness criteria), association between AEs and study drug exposure parameters, and physical examination

  Up to 1 month post discharge

• Mean difference in ECG HR values in BMS-986104-treated versus placebo-treated healthy male subjects, identifying nadir ECG HR

  Day -1 up to 24h and Days 1-5

• Percent reduction in ECG HR

  Day -1 up to 24h and Days 1-5

• Time to nadir ECG HR

  Day -1 up to 24h and Days 1-5

• Maximum observed blood concentration (Cmax) of BMS-986104

  Up to Day 56

Study Arms (4)

Panel 1: BMS-986104 or Placebo

EXPERIMENTAL

BMS-986104 or Placebo single dose by mouth as specified

Drug: BMS-986104; Drug: Placebo

Panel 2: BMS-986104 or Placebo

EXPERIMENTAL

BMS-986104 or Placebo single dose by mouth as specified

Drug: BMS-986104; Drug: Placebo

Panel 3: BMS-986104 or Placebo

EXPERIMENTAL

BMS-986104 or Placebo single dose by mouth as specified

Drug: BMS-986104; Drug: Placebo

Panel 4: BMS-986104 or Placebo

EXPERIMENTAL

BMS-986104 or Placebo single dose by mouth as specified

Drug: BMS-986104; Drug: Placebo

Interventions

BMS-986104 DRUG

Panel 1: BMS-986104 or Placebo; Panel 2: BMS-986104 or Placebo; Panel 3: BMS-986104 or Placebo; Panel 4: BMS-986104 or Placebo

Placebo DRUG

Panel 1: BMS-986104 or Placebo; Panel 2: BMS-986104 or Placebo; Panel 3: BMS-986104 or Placebo; Panel 4: BMS-986104 or Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, 53704, United States

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

1-amino-3-((R)-6-hexyl-5,6,7,8-tetrahydronaphthalen-2-yl)cyclopentyl)methanol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 7, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 18, 2015

Record last verified: 2015-04

Locations

US (1)