We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00901498
First Posted: May 13, 2009
Last Update Posted: January 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  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
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

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 ]

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
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:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00901498     History of Changes
Other Study ID Numbers: CN156-004
First Submitted: May 5, 2009
First Posted: May 13, 2009
Last Update Posted: January 7, 2011
Last Verified: August 2009

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders


To Top