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| Sponsored by: |
Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00533026 |
Purpose
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. All subjects will begin dosing with warfarin, then after approximately 12 days, duloxetine 60 mg is added and subjects with stabilized INR will either continue dosing at 60 mg or have a dose increase to 120 mg.
| Condition | Intervention | Phase |
|---|---|---|
|
Anticoagulant Effect of Warfarin When Taken With Duloxetine. |
Drug: Duloxetine Drug: Warfarin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Open Label, Active Control, Single Group Assignment, Pharmacodynamics Study |
| Official Title: | Evaluation of the Effect of Duloxetine on the Pharmacodynamics of Warfarin at Steady-State in Healthy Subjects |
| Enrollment: | 60 |
| Study Start Date: | July 2007 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
Subjects received warfarin QD, PO for approximately 12 days. Subjects with stabilized INR after approximately 12 days continued to receive warfarin QD, PO for an additional 14 days and also received duloxetine 60mg QD, PO for the 14 days. Duloxetine doses were tapered, subjects received 30mg QD, PO for 4 days. No warfarin was received during the taper phase.
|
Drug: Duloxetine Drug: Warfarin |
|
B: Active Comparator
Subjects received warfarin QD, PO for approximately 12 days. Subjects with stabilized INR after approximately 12 days continued to receive warfarin QD, PO for an additional 14 days and also received duloxetine 60 mg QD, PO for 4 days followed by duloxetine 120 mg QD, PO for 10 days. Duloxetine doses were tapered, subjects received 60mg QD, PO for 4 days followed by 30mg QD, PO for 4 days. No warfarin was received during the taper phase.
|
Drug: Duloxetine Drug: Warfarin |
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United Kingdom, West Yorkshire | |
| 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 | |
| Study Director: | 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) | Eli Lilly and Company |
More Information
| Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 11707, F1J-MC-HMFP |
| Study First Received: | September 19, 2007 |
| Last Updated: | September 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00533026 History of Changes |
| Health Authority: | United Kingdom: Research Ethics Committee |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Anticoagulants Adrenergic Agents Psychotropic Drugs Healthy Warfarin |
Serotonin Uptake Inhibitors Duloxetine Serotonin Dopamine Dopamine Agents Antidepressive Agents |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Anticoagulants Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Hematologic Agents Physiological Effects of Drugs Psychotropic Drugs |
Warfarin Serotonin Uptake Inhibitors Duloxetine Pharmacologic Actions Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents Antidepressive Agents |
