Duloxetine - Warfarin Pharmacodynamic Study
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anticoagulant Effect of Warfarin When Taken With Duloxetine.
Intervention: Duloxetine (Drug); Warfarin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Summary
To evaluate the blood clotting effects of multiple doses of warfarin at steady state when
taken at the same time as multiple doses of duloxetine as measured by changes in the
International Normalised Ratio.
Clinical Details
Official title: Evaluation of the Effect of Duloxetine on the Pharmacodynamics of Warfarin at Steady-State in Healthy Subjects
Study design: Basic Science, Randomized, Open Label, Active Control, Single Group Assignment, Pharmacodynamics Study
Primary outcome: To evaluate the anticoagulant effects of multiple doses of warfarin at steady state when taken concomitantly with multiple doses of duloxetine as measured by changes in the INR (International Normalized Ratio).
Secondary outcome: Evaluate the effect of duloxetine on the pharmacokinetics of warfarin, the safety/ tolerability of duloxetine and warfarin given in combination, and the platelet function determined by bleeding times when duloxetine and warfarin are given in combination.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Healthy men or women between ages 18 and 64 years.
Exclusion Criteria:
Have a personal history, family history of, or current evidence of: a bleeding disorder,
have Positive Faecal Occult Blood (FOB) sample at screening, significant neuropsychiatric
disease (including a history of suicide attempts or who have exhibited suicidal ideation or
who are at significant risk to commit suicide, as judged by the investigator), significant
active respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or
neurological disorders.
Use or intended use of aspirin or NSAIDs within 2 weeks prior to first dosing.
Subjects who have an average weekly alcohol intake that exceeds 28 units per week (males)
and 21 units per week (females). Subjects who smoke more than 5 cigarettes per day.
Use or intended us of a drug that inhibits or induces CYP1A2 or inhibits CYP2D6 within 2
weeks prior to first dosing occasion or during the study.
Have received any drug that acts as a monoamine oxidase inhibitor (MAOI) within 2 weeks
prior to first dosing occasion or have a potential need to use an MAOI during the conduct
of this study or within 2 weeks after discontinuation of study drug.
Locations and Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Leeds, West Yorkshire, United Kingdom
Additional Information
Lilly Clinical Trial Registry
Starting date: July 2007
Last updated: December 17, 2007
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