Clinical trial NCT00533026: Duloxetine - Warfarin Pharmacodynamic Study
Official title: Evaluation of the Effect of Duloxetine on the Pharmacodynamics of Warfarin at Steady-State in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anticoagulant Effect of Warfarin When Taken With Duloxetine.
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility 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.

Primary outcomes:
measure: International Normalized Ratio (INR)
timeFrame: 58 days
Secondary outcomes:
measure: Effect of duloxetine on pharmacokinetics of warfarin.
timeFrame: 58 days
measure: Safety/ tolerability of duloxetine and warfarin given in combination.
timeFrame: 58 days
measure: Bleeding times when duloxetine and warfarin are given in combination.
timeFrame: 58 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: 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
state: West Yorkshire
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: