A Phase I Study To Estimate The Effect Of Ketoconazole And Omeprazole On The Pharmacokinetics Of Dimebon In Healthy Subjects Who Are Normal Or Poor CYP2D6 Metabolizers
NCT ID: NCT00931073
Last Updated: 2009-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2009-07-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
CROSSOVER
NONE
Study Groups
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Period 1
Dimebon alone
Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening
Period 2
Dimebon + Ketoconazole
Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed on Day 4 during the daily administration of ketoconazole (400 mg, Day 1-11) in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening
Period 3
Dimebon + Omeprazole
Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed on Day 5 during the daily administration of omeprazole(40 mg, Day 1-12) in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening
Interventions
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Dimebon alone
Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening
Dimebon + Ketoconazole
Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed on Day 4 during the daily administration of ketoconazole (400 mg, Day 1-11) in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening
Dimebon + Omeprazole
Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed on Day 5 during the daily administration of omeprazole(40 mg, Day 1-12) in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening
Eligibility Criteria
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Inclusion Criteria
* Subjects must have either a CYP2D6 EM (n=12) or PM (n=12) status based on genotyping at screening.
* Subjects must have a CYP2C19 EM status based on status at screening.
Exclusion Criteria
* Subjects with any history of a previous seizure or convulsion or significant head trauma.
* Subjects specifically allergic to imidazole antifungal agents.
* Subjects specifically allergic to omeprazole or other proton pump inhibitors.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Subjects with hypersensitivity reactions to Dimebon or other antihistamines.
* Consumption of grapefruit or grapefruit containing products within 7 days prior to the first dose of study medication.
* Subjects currently taking omeprazole, other proton pump inhibitors, antacids, H2-blockers or CYP2C19 inhibitors.
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
18 Years
55 Years
ALL
Yes
Sponsors
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Medivation, Inc.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Kalamazoo, Michigan, United States
Countries
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Related Links
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Other Identifiers
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B1451017
Identifier Type: -
Identifier Source: org_study_id