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

Primary Purpose

Alzheimer Disease, Huntington Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

digoxin

dimebon

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring digoxin dimebon drug-drug interaction study

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

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

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).

Outcomes

Primary Outcome Measures

AUC24 and Cmin of digoxin on Day 14

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00831506

First Posted

January 27, 2009

Last Updated

June 9, 2009

Sponsor

Pfizer

Collaborators

Medivation, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00831506

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

Collaborators

Medivation, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Huntington Disease

Keywords

digoxin dimebon drug-drug interaction study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

digoxin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

digoxin

Intervention Description

digoxin once daily (0.125 mg QD) for 14 days.

Intervention Type

Drug

Intervention Name(s)

dimebon

Intervention Description

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 Measure Information:

Title

AUC24 and Cmin of digoxin on Day 14

Time Frame

Day 14

Secondary Outcome Measure Information:

Title

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

Time Frame

Day 14

Title

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

Time Frame

Day 14

Title

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

Time Frame

Day 14

Title

12-lead ECGs through Day 14

Time Frame

Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1451021&StudyName=Dimebon%20%28PF-01913539%29-Digoxin%20Drug-Drug%20Interaction%20Study%20In%20Healthy%20Subjects

Description

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

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