Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-933043 in Healthy Subjects
NCT ID: NCT01605994
Last Updated: 2014-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
115 participants
INTERVENTIONAL
2012-07-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Panel 1:BMS-933043(2mg)/Placebo+Antacid Buffer Solution
BMS-933043 2 mg solution by mouth twice daily for 10 days
OR
Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days
Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days
BMS-933043
Placebo matching with BMS-933043
Antacid Buffer Predose Solution
Panel 2:BMS-933043(5mg)/Placebo+Antacid Buffer Solution
BMS-933043 5 mg solution by mouth twice daily for 10 days
OR
Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days
Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days
BMS-933043
Placebo matching with BMS-933043
Antacid Buffer Predose Solution
Panel 3:BMS-933043(10mg)/Placebo+Antacid Buffer Solution
BMS-933043 10 mg solution by mouth twice daily for 10 days
OR
Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days
Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days
BMS-933043
Placebo matching with BMS-933043
Antacid Buffer Predose Solution
Panel 4:BMS-933043(25mg)/Placebo+Antacid Buffer Solution
BMS-933043 25 mg solution by mouth twice daily for 10 days
OR
Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days
Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days
BMS-933043
Placebo matching with BMS-933043
Antacid Buffer Predose Solution
Panel 5:BMS-933043(50mg)/Placebo+Antacid Buffer Solution
BMS-933043 50 mg solution by mouth twice daily for 10 days
OR
Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days
Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days
CSF sampling required
BMS-933043
Placebo matching with BMS-933043
Antacid Buffer Predose Solution
Panel 6:BMS-933043(100mg)/Placebo+Antacid Buffer Solution
BMS-933043 100 mg solution by mouth twice daily for 10 days
OR
Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days
Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days
BMS-933043
Placebo matching with BMS-933043
Antacid Buffer Predose Solution
Panel 7:BMS-933043(200mg)/Placebo+Antacid Buffer Solution
BMS-933043 200 mg solution by mouth twice daily for 10 days
OR
Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days
Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days
BMS-933043
Placebo matching with BMS-933043
Antacid Buffer Predose Solution
Panel 8:BMS-933043(25mg)/Placebo+Antacid Buffer Predose
MAD Phase: Japanese Subjects. Cerebrospinal fluid (CSF) sampling not required
BMS-933043 25 mg solution by mouth twice daily for 10 days
OR
Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days
Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days
BMS-933043
Placebo matching with BMS-933043
Antacid Buffer Predose Solution
Panel 9:BMS-933043(200mg)/Placebo+Antacid Buffer Predose
Japanese Subjects. CSF sampling not required.
BMS-933043 200 mg solution by mouth twice daily for 10 days
OR
Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days
Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days
BMS-933043
Placebo matching with BMS-933043
Antacid Buffer Predose Solution
Panel 10:BMS-933043(350mg)/Placebo+Antacid Buffer Predose
BMS-933043 350 mg solution by mouth twice daily for 10 days
OR
Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days
Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days
BMS-933043
Placebo matching with BMS-933043
Antacid Buffer Predose Solution
CSF Panel:BMS-933043(MTD)/Placebo+Antacid Buffer Predose
If Panel 5 does not run. CSF Sampling at steady state
BMS-933043 maximum tolerated dose (MTD), solution by mouth twice daily for 10 days
OR
Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days
Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days
BMS-933043
Placebo matching with BMS-933043
Antacid Buffer Predose Solution
Interventions
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BMS-933043
Placebo matching with BMS-933043
Antacid Buffer Predose Solution
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Clinilabs, Inc.
New York, New York, United States
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CN171-002
Identifier Type: -
Identifier Source: org_study_id
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