CompletedPhase 1

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

Lead sponsor

Pfizer

Asset

Dimebon

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-55

Primary endpoint

•AUC24 and Cmin of digoxin on Day 14

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDB1451021

NCT IDNCT00831506

Timeline

Milestones

Study first posted2009-01-29estimated

Study start2009-02 (month precision)

Primary completion2009-05actual (month precision)

Study completion2009-05actual (month precision)

Last update posted2009-06-12estimated

Assets

Drug assets

Dimebon

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

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.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

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

Time frame:Day 14

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Day 14

event count, event

Secondary/protocol endpoint

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

Time frame:Day 14

descriptive

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

AUC24 and Cmin of digoxin on Day 14

Time frame:Day 14

descriptive

Secondary/protocol endpoint/low confidence

12-lead ECGs through Day 14

Time frame:Day 14

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.