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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Alzheimer's Disease

Huntington's Disease

Treatments

Drug: Dimebon + Omeprazole

Drug: Dimebon + Ketoconazole

Drug: Dimebon alone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00931073

B1451017

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.