NCT00831506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 alzheimer-disease

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 12, 2009

Status Verified

June 1, 2009

Enrollment Period

3 months

First QC Date

January 27, 2009

Last Update Submit

June 9, 2009

Conditions

Alzheimer DiseaseHuntington Disease

Keywords

digoxin dimebon drug-drug interaction study

Outcome Measures

Primary Outcomes (1)

  • AUC24 and Cmin of digoxin on Day 14

    Day 14

Secondary Outcomes (4)

  • 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

Study Arms (2)

A

EXPERIMENTAL

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

Drug: digoxin

B

EXPERIMENTAL

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).

Drug: digoxinDrug: dimebon

Interventions

digoxinDRUG

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

A
dimebonDRUG

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

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseHuntington Disease

Interventions

Digoxinlatrepirdine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBasal Ganglia DiseasesChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition Disorders

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 29, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

June 12, 2009

Record last verified: 2009-06

Locations

US(1)