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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
With
Medivation, Inc.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.
