Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease
A Bioavailability Study of Four Experimental BMS-708163 Formulations Relative to Solubilized Capsule Formulation in Healthy Young Male Subjects
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 5, 2009
CompletedFirst Posted
Study publicly available on registry
May 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJanuary 7, 2011
August 1, 2009
2 months
May 5, 2009
January 6, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the bioavailability of 4 experimental formulations relative to the current reference formulation
Day 1, up to 3 weeks
Secondary Outcomes (4)
Safety: Adverse Events
Day 1, up to 3 weeks
Safety: Vital Signs
Screening, Day 1 and Day 4 of each period
Safety: ECGs
Screening, Day 1 of each period, up to 3 weeks
Safety: Clinical Lab Tests
Screening, Day -1 of each period, Day 1, up to 3 weeks
Study Arms (5)
Treatment A (Reference)
EXPERIMENTALTreatment B
ACTIVE COMPARATORTreatment C
ACTIVE COMPARATORTreatment D
ACTIVE COMPARATORTreatment E
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Young healthy male subjects
You may not qualify if:
- Women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mds Pharma Services (Us) Inc.
Neptune City, New Jersey, 07753, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 5, 2009
First Posted
May 13, 2009
Study Start
May 1, 2009
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
January 7, 2011
Record last verified: 2009-08