A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF 01913539) On The Single-Dose Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects

NCT00827034 | Completed Phase 1

• 1 other identifier: B1451020
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the potential drug-drug interaction of Dimebon with the FDA-recommended CYP2C9 substrate warfarin in healthy subjects. Conformance with the guidance includes general study design using a randomized, open label, single-dose warfarin, steady-state Dimebon, 2-sequence, 2-treatment, 2-period crossover design with a minimum 7-day washout period between treatments.

Conditions

Alzheimer's Disease; Huntington's Disease

Keywords

Dimebon Warfarin Drug-Drug Interaction

Outcome Measures

Primary Outcomes (3)

• Single dose pharmacokinetics (Cmax, AUCinf) of warfarin 25 mg with and without co-administration of steady-state Dimebon 20 mg TID in healthy adult subjects.

  7+18 days

• Single dose pharmacodynamics (INRmax, AUC-INR) of warfarin 25 mg with and without co-administration of steady-state Dimebon 20 mg TID in healthy adult subjects.

  7+18 days

• Safety and tolerability ( adverse event monitoring, physical examinations, vital signs, ECG's and clinical laboratory tests) of multiple doses of Dimebon 20 mg TID with a single dose of warfarin 25 mg in healthy adult subjects.

  7+18 days

Study Arms (2)

A

OTHER

A: Warfarin alone

Drug: Warfarin

B

OTHER

B: Dimebon and Warfarin co-administration

Drug: Dimebon; Drug: Warfarin

Interventions

Warfarin DRUG

A: a single oral dose of warfarin 25 mg administered on Day 1 of the relevant dosing period, as tablets.

A

Dimebon DRUG

B is oral doses of Dimebon 10 mg TID on Days 1 7 and Dimebon 20 mg TID on Days 8 17, with co administration of a single oral dose of warfarin 25 mg on Day 12 of the relevant dosing period, both as tablets

B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female (non-childbearing potential) 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).
• Prothrombin time (PT)/INR, and partial thromboplastin time (PTT).
• Plasma Protein C and Protein S activity (functional) within the normal reference range.

You may not qualify if:

• A known sensitivity or previous intolerance to Dimebon or warfarin.
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
• Subjects receiving warfarin for treatment of active thromboembolic events (ie, pulmonary embolism, deep vein thrombosis), as well as subjects anticoagulated with prosthetic heart valves.

Sponsors & Collaborators

• Pfizer: lead
• Medivation, Inc.: collaborator

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alzheimer Disease; Huntington Disease

Interventions

Warfarin; latrepirdine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Basal Ganglia Diseases; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 22, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

US (1)