Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease - Full Text View

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Genetic and Rare Diseases Information Center resources: Alzheimer Disease Familial

U.S. FDA Resources

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:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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 March 03, 2015