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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease; Huntington's Disease

Intervention: Dimebon alone (Drug); Dimebon + Ketoconazole (Drug); Dimebon + Omeprazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Dimebon alone: Dimebon PK in CYP2D6 EMs and PMs (Cmax, Tmax, AUCinf (as data permit), AUClast, and t1/2 (as data permit), CL/F (as data permit) and V/F (as data permit))

Dimebon + keto: Dimebon PK in CYP2D6 EMs and PMs (Cmax, Tmax, AUCinf (as data permit), AUClast, and t1/2 (as data permit), CL/F (as data permit) and V/F (as data permit))

Dimebon + omeprazole: Dimebon PK in CYP2D6 EMs and PMs (Cmax, Tmax, AUCinf (as data permit), AUClast, and t1/2 (as data permit), CL/F (as data permit) and V/F (as data permit))

Secondary outcome:

Dimebon alone: Safety and tolerability (AE's, ECG, vital signs, safety labs)

Dimebon + keto: Safety and tolerability (AE's, ECG, vital signs, safety labs)

Dimebon + omeprazole: Safety and tolerability (AE's, ECG, vital signs, safety labs)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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 and Contacts

Pfizer Investigational Site, Kalamazoo, Michigan 49007, United States
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2009
Last updated: November 17, 2009

Page last updated: August 23, 2015

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