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Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00901498
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : January 7, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Healthy Drug: BMS-708163 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Bioavailability Study of Four Experimental BMS-708163 Formulations Relative to Solubilized Capsule Formulation in Healthy Young Male Subjects
Study Start Date : May 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment A (Reference) Drug: BMS-708163
Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.
Active Comparator: Treatment B Drug: BMS-708163
Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings
Active Comparator: Treatment C Drug: BMS-708163
Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings
Active Comparator: Treatment D Drug: BMS-708163
Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings
Active Comparator: Treatment E Drug: BMS-708163
Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings


Outcome Measures
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Primary Outcome Measures :
  1. To assess the bioavailability of 4 experimental formulations relative to the current reference formulation [ Time Frame: Day 1, up to 3 weeks ]

Secondary Outcome Measures :
  1. Safety: Adverse Events [ Time Frame: Day 1, up to 3 weeks ]
  2. Safety: Vital Signs [ Time Frame: Screening, Day 1 and Day 4 of each period ]
  3. Safety: ECGs [ Time Frame: Screening, Day 1 of each period, up to 3 weeks ]
  4. Safety: Clinical Lab Tests [ Time Frame: Screening, Day -1 of each period, Day 1, up to 3 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Young healthy male subjects

Exclusion Criteria:

  • Women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901498


Locations
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United States, New Jersey
Mds Pharma Services (Us) Inc.
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00901498    
Other Study ID Numbers: CN156-004
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: January 7, 2011
Last Verified: August 2009
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders