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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 | Clinical Trials | Clareo Health

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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

A Phase I, Open-Label, Three-Period, Fixed-Sequence Study To Estimate The Steady-State Effect Of Ketoconazole And Omeprazole On The Single-Dose Pharmacokinetics Of Dimebon [PF-01913539] In Healthy CYP2D6 EM And PM Subjects

NCT00931073•Pfizer

View on ClinicalTrials.gov

Summary

This study will evaluate the potential for a drug-drug interaction of Dimebon with ketoconazole and omeprazole, potent inhibitors of the drug metabolizing enzymes CYP3A4 and CYP2C19, respectively.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
•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

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
•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.

Locations (1)

Pfizer Investigational Site

Kalamazoo, Michigan, United States

Key Dates

Start Date

July 1, 2009

Primary Completion Date

October 1, 2009

Completion Date

October 1, 2009

Last Updated

November 18, 2009

Enrollment

ESTIMATED participants

Conditions

Alzheimer's DiseaseHuntington's Disease

Interventions

Dimebon alone

DRUG

Dimebon + Ketoconazole

DRUG

Dimebon + Omeprazole

DRUG

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RECRUITING

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Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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