Trial record 2 of 13 for:
"BMS-708163"
Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00860275
First received: March 11, 2009
Last updated: January 24, 2011
Last verified: July 2009
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy 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:
- PK profile of BMS-708163 [ Time Frame: Within 14 days after dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole [ Time Frame: During the entire study period ] [ Designated as safety issue: Yes ]
| Enrollment: | 30 |
| Study Start Date: | April 2009 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: BMS-708163 / Ketoconazole |
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
|
| Active Comparator: BMS-708163 / Fluconazole |
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 |
Criteria
Inclusion Criteria:
- Healthy male and postmenopausal female subjects 18-55 yrs old inclusive
Exclusion:
- Premenopausal women
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers squibb |
| ClinicalTrials.gov Identifier: | NCT00860275 History of Changes |
| Other Study ID Numbers: | CN156-019 |
| Study First Received: | March 11, 2009 |
| Last Updated: | January 24, 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 Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Fluconazole Ketoconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013