The Effects of Multiple Dose Fluoxetine and Metabolites on CYP1A2, CYP2C19, CYP2D6 and CYP3A4 Activity (FLUOXETINE)
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|ClinicalTrials.gov Identifier: NCT01361217|
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : June 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Drug-Drug Interaction Healthy Volunteers||Drug: Fluoxetine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of Multiple Dose Fluoxetine and Metabolites on CYP1A2, CYP2C19, CYP2D6 and CYP3A4 Activity|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: Fluoxetine DDI
Only arm in the study. Successive Control (Study Days 1 and 3) and fluoxetine multiple-dose treatment (Study Days 16 and 18) Sessions.
1x20mg oral fluoxetine capsules by mouth daily on Study Day 5, then 3x20mg fluoxetine capsules by mouth daily on Study Days 6 through 18.
Other Name: Prozac
- Fluoxetine-CYP3A4 DDI [ Time Frame: The primary outcome will be assessed within 2 months after the last subject is enrolled or at 2 years from the start of study enrollment, which ever is sooner. ]Our primary outcome measure will be the interaction of fluoxetine with CYP3A4. A 50% increase in the AUC for lovastatin plus hydroxylovastatin acid (the active form of lovastatin) between treatment and control days is considered clinically significant.
- Fluoxetine-Cocktail DDI [ Time Frame: The secondary outcome will be assessed within 2 months after the last subject is enrolled or at 2 years from the start of study enrollment, which ever is sooner. ]Our secondary outcome measure will be the interaction between fluoxetine and each CYP evaluated in the cocktail. A 50% increase in the AUC of caffeine (CYP1A2), dextromethorphan (CYP2D6), omeprazole (CYP2C19) or midazolam (CYP3A4) between treatment and control days is considered clinically significant. The interaction of fluoxetine with caffeine (CYP1A2) will be considered as a negative control for the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361217
|United States, Washington|
|University of Washington, Institute of Translational Health Sciences, Clinical Research Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Nina Isoherranen, PhD.||University of Washington, School of Pharmacy, Department of Pharmaceutics|
|Principal Investigator:||Connie Davis, MD.||University of Washington, Department of Medicine|