Trial record 7 of 13 for:    "BMS-708163"

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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00901498
First received: May 5, 2009
Last updated: January 6, 2011
Last verified: August 2009
  Purpose

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 Intervention Phase
Alzheimer's Disease
Healthy
Drug: BMS-708163
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Bioavailability Study of Four Experimental BMS-708163 Formulations Relative to Solubilized Capsule Formulation in Healthy Young Male Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To assess the bioavailability of 4 experimental formulations relative to the current reference formulation [ Time Frame: Day 1, up to 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Adverse Events [ Time Frame: Day 1, up to 3 weeks ] [ Designated as safety issue: Yes ]
  • Safety: Vital Signs [ Time Frame: Screening, Day 1 and Day 4 of each period ] [ Designated as safety issue: Yes ]
  • Safety: ECGs [ Time Frame: Screening, Day 1 of each period, up to 3 weeks ] [ Designated as safety issue: Yes ]
  • Safety: Clinical Lab Tests [ Time Frame: Screening, Day -1 of each period, Day 1, up to 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Young healthy male subjects

Exclusion Criteria:

  • Women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901498

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

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00901498     History of Changes
Other Study ID Numbers: CN156-004
Study First Received: May 5, 2009
Last Updated: January 6, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014