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

Phase 1

Completed

• Conditions: Alzheimer's Disease; Healthy
• Interventions: Drug: BMS-708163

• Registration Number: NCT00901498
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-05-12
• Study First Posted: 2009-05-13
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2009-08
• Last Update Submitted: 2011-01-06
• Last Update Posted: 2011-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• Young healthy male subjects

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Exclusion Criteria

• Women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A (Reference)	BMS-708163	-
Treatment B	BMS-708163	-
Treatment D	BMS-708163	-
Treatment E	BMS-708163	-
Treatment C	BMS-708163	-

Primary Outcome Measures

Name	Time	Method
To assess the bioavailability of 4 experimental formulations relative to the current reference formulation	Day 1, up to 3 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mds Pharma Services (Us) Inc.; 🇺🇸 Neptune, New Jersey, United States