Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00901498
First received: May 5, 2009
Last updated: January 6, 2011
Last verified: August 2009
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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
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 (Adult) |
| 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
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:
| 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 Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 28, 2016