Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-933043 in Healthy Subjects

Bristol-Myers Squibb115 enrolled

Overview

Includes a placebo-controlled sequential, ascending multiple-dose panels (10 panels, 8 ascending doses, and 2 fixed Japanese Panels exploring safety, tolerability, and Pharmacokinetic (PK) measures

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

115

Conditions

Healthy Adult Normals

Interventions

BMS-933043DRUG

Placebo matching with BMS-933043DRUG

Antacid Buffer Predose SolutionDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations * Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2 * Normal Neurological Exam (LP subjects only: to rule out focal CNS lesions that would render LP unsafe) * Men and women, ages 18 to 55 years, inclusive. * Women who are not of childbearing potential (WOCBP) \[ie, who are postmenopausal or surgically sterile\] and men * Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product. * Women must not be breastfeeding * Sexually active fertile men must use effective birth control if their partners are WOCBP throughout the study and for 90 days after last dose Exclusion Criteria: * Any significant acute or chronic medical illness * Current or recent (within 3 months of study drug administration) gastrointestinal disease * Any major surgery within 4 weeks of study drug administration * Any gastrointestinal surgery that could impact upon the absorption of study drug * Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration * Blood transfusion within 4 weeks of study drug administration * Inability to tolerate oral medication * Inability to be venipunctured and/or tolerate venous access * Smoking more than 1 cigarette/cigar per week, within 3 months prior to screening * Regular daily use of nicotine products or Varenicline (Chantix® or Champix®) within 3 months prior to screening * Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (4th Edition) \[DSM IV\], Diagnostic Criteria for Drug and Alcohol Abuse * History of cardiac arrhythmias, or palpitations associated with presyncope or syncope or history of unexplained syncope

Locations (1)

Clinilabs, Inc.

New York, New York, United States

Outcomes

Primary Outcomes

Safety and tolerability of multiple oral doses of BMS-933043 in healthy subjects measured by AEs, Vital signs, clinical laboratory test results, physical examination findings, neurological examination findings and electrocardiogram (ECG) parameters

AEs = Adverse Events

Time frame: Up to Day 26 of Follow-up