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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831506
• Other study ID #: B1451021
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2009
• Last updated: June 9, 2009
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Huntington Disease

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Medivation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC24 and Cmin of digoxin on Day 14		Day 14	No
Secondary	Cmax, Tmax, Ae, and renal clearance of digoxin on Day 14		Day 14	No
Secondary	Adverse event monitoring through Day 14 including physical/neurological examination findings		Day 14	Yes
Secondary	Clinical safety assessments through Day 14 including chemistry, hematology, and vital signs		Day 14	Yes
Secondary	12-lead ECGs through Day 14		Day 14	Yes

External Links

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