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| Sponsored by: |
Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00860275 |
Purpose
The purpose of the study is to determine if the concomitant administration of either ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess safety and tolerability of BMS-708163
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: BMS-708163 Drug: BMS-708163 + Ketoconazole Drug: Ketoconazole Drug: Fluconazole Drug: BMS-708163 + Fluconazole |
Phase I |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy Subjects |
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| BMS-708163 / Ketoconazole: Active Comparator |
Drug: BMS-708163
Capsule, Oral, 50 mg, once, Day 1
Drug: BMS-708163 + Ketoconazole
(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day
Drug: Ketoconazole
Tablet, Oral, 400 mg, daily, 16 days
|
| BMS-708163 / Fluconazole: Active Comparator |
Drug: BMS-708163
Capsule, Oral, 50 mg, once, Day 1
Drug: Fluconazole
Tablet, Oral, 1 day 400 mg then 3 days 200 mg
Drug: BMS-708163 + Fluconazole
(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion:
Contacts and Locations| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
| United States, Texas | |
| Ppd Development, Lp | Recruiting |
| Austin, Texas, United States, 78744 | |
| Contact: Matthew M. Medlock, Site 001 | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Responsible Party: | Bristol-Myers squibb ( Study Director ) |
| Study ID Numbers: | CN156-019 |
| Study First Received: | March 11, 2009 |
| Last Updated: | May 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00860275 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Fluconazole Clotrimazole Miconazole Alzheimer Disease Tioconazole Central Nervous System Diseases Healthy Brain Diseases |
Neurodegenerative Diseases Ketoconazole Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Antifungal Agents Dementia Delirium |
|
Fluconazole Anti-Infective Agents Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Ketoconazole |
Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Antifungal Agents Dementia Tauopathies |
