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Completed

NCT Number: NCT00901498

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Healthy Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Mds Pharma Services (Us) Inc.

Neptune City, New Jersey, 07753, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Young healthy male subjects

Exclusion criteria

  • Women

Treatment and study plan

BMS-708163

Drug

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.

Primary outcomes

  1. To assess the bioavailability of 4 experimental formulations relative to the current reference formulation

    Time frame: Day 1, up to 3 weeks

Secondary outcomes

  1. Safety: Adverse Events

    Time frame: Day 1, up to 3 weeks

  2. Safety: Vital Signs

    Time frame: Screening, Day 1 and Day 4 of each period

  3. Safety: ECGs

    Time frame: Screening, Day 1 of each period, up to 3 weeks

  4. Safety: Clinical Lab Tests

    Time frame: Screening, Day -1 of each period, Day 1, up to 3 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Bioavailability Study of Four Experimental BMS-708163 Formulations Relative to Solubilized Capsule Formulation in Healthy Young Male Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 13, 2009
Registry last updated
Jan 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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