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

Phase 1

Completed

• Conditions: Alzheimer Disease; Huntington Disease
• Interventions: Drug: digoxin; Drug: dimebon

• Registration Number: NCT00831506
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-29
• Study Start: 2009-02
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-09
• Last Update Posted: 2009-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	digoxin	digoxin once daily (0.125 mg QD) plus placebo three times daily (TID), 8 hours apart for 14 days.
B	digoxin	digoxin once daily (0.125 mg QD) plus Dimebon three times a day, 8 hours apart for 14 days (10 mg TID on Days 1-7 and 20 mg TID on Days 8-14).
B	dimebon	digoxin once daily (0.125 mg QD) plus Dimebon three times a day, 8 hours apart for 14 days (10 mg TID on Days 1-7 and 20 mg TID on Days 8-14).

Primary Outcome Measures

Name	Time	Method
AUC24 and Cmin of digoxin on Day 14	Day 14

Secondary Outcome Measures

Name	Time	Method
Cmax, Tmax, Ae, and renal clearance of digoxin on Day 14	Day 14
Adverse event monitoring through Day 14 including physical/neurological examination findings	Day 14
Clinical safety assessments through Day 14 including chemistry, hematology, and vital signs	Day 14
12-lead ECGs through Day 14	Day 14

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States