Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT00901498 |
Recruitment Status :
Completed
First Posted : May 13, 2009
Last Update Posted : January 7, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease Healthy | Drug: BMS-708163 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
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 |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
---|---|
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 |
- To assess the bioavailability of 4 experimental formulations relative to the current reference formulation [ Time Frame: Day 1, up to 3 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Young healthy male subjects
Exclusion Criteria:
- Women

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
United States, New Jersey | |
Mds Pharma Services (Us) Inc. | |
Neptune, New Jersey, United States, 07753 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Study Director, Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00901498 |
Other Study ID Numbers: |
CN156-004 |
First Posted: | May 13, 2009 Key Record Dates |
Last Update Posted: | January 7, 2011 |
Last Verified: | August 2009 |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |