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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014