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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00831506

Enrollment

Registered

2009-01-29

Start date

2009-02-28

Completion date

2009-05-31

Last updated

2009-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Huntington Disease

Keywords

digoxin dimebon drug-drug interaction study

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.

Interventions

DRUGdigoxin

digoxin once daily (0.125 mg QD) plus placebo three times daily (TID), 8 hours apart for 14 days.

DRUGdimebon

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).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
AUC24 and Cmin of digoxin on Day 14	Day 14

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026