Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects

Condition(s) targeted: Alzheimer Disease; Huntington Disease

Intervention: digoxin (Drug); digoxin (Drug); dimebon (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Pfizer

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

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

This study has been designed to confirm, in healthy subjects, the lack of a clinically important pharmacokinetic interaction between Dimebon, at the proposed maximum commercial dose of 20 mg TID (administered every 8 hours), and digoxin (Lanoxin®) 0. 125 mg QD, a sensitive P-gp substrate recommended by FDA.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF-01913539) On The Safety, Tolerability, And Steady-State Pharmacokinetics Of Digoxin In Healthy Subjects

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacokinetics Study

Primary outcome: AUC24 and Cmin of digoxin on Day 14

Secondary outcome:

Cmax, Tmax, Ae, and renal clearance of digoxin on Day 14

Adverse event monitoring through Day 14 including physical/neurological examination findings

Clinical safety assessments through Day 14 including chemistry, hematology, and vital signs

12-lead ECGs through Day 14

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

Criteria:

Inclusion Criteria:

- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive

(Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

- Body Mass Index (BMI) of 17. 5 to 30. 5 kg/m2; and a total body weight >50 kg (110

lbs).

Exclusion Criteria:

- A known history of hypersensitivity or previous intolerance to Dimebon or digoxin.

- Evidence or history of clinically significant hematological, renal,

endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing) disease or clinical findings at screening.

- Pregnant or nursing women; women of childbearing potential (WOCBP) who are unwilling

or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to the first dose of study medication.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

Starting date: February 2009
Ending date: May 2009
Last updated: January 27, 2009