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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT00827034
Date of registration: 20/01/2009
Prospective Registration: Yes
Primary sponsor: Pfizer
Public title: 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
Scientific title: 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
Date of first enrolment: February 2009
Target sample size: 14
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00827034
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All
Health Condition(s) or Problem(s) studied
Alzheimer's Disease
Huntington's Disease
Intervention(s)
Drug: Dimebon
Drug: Warfarin
Primary Outcome(s)
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. [Time Frame: 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. [Time Frame: 7+18 days]
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. [Time Frame: 7+18 days]
Secondary Outcome(s)
Secondary ID(s)
B1451020
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Medivation, Inc.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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