Effects of Gastric Bypass on Blood Levels of Duloxetine

Study Overview
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Brief Summary
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This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.

Official Title
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A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine

Conditions
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Bariatric Surgery

Intervention / Treatment
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* Drug: Duloxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects between the ages of 18 and 60 years. Subjects must be of good general health by history and physical exam. Ten experimental subjects 9 to 15 months post bariatric surgery (Roux-en-Y procedure), no BMI requirement. Ten normal control subjects who have met the inclusion criteria and have not received bariatric surgery and who are matched to the surgery subjects according to body mass index, age and sex. Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline. No contraindications to receiving a single capsule of 60 mg of duloxetine Exclusion Criteria: Allergy to duloxetine or any of its constituents. Candidates who are pregnant or nursing Candidates currently receiving any antidepressant. Candidates that are determined to be poor metabolizers for CYP2D6 Subjects who smoke or use any nicotine products Candidates currently receiving a medication that interacts with duloxetine. Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease. Candidates experiencing or with a history of vomiting or diarrhea associated with bariatric surgery Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder. Candidates who have participated in an investigational drug study in past 30 days. Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or who have a history of drug/alcohol abuse or dependency.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active drug<br>All subjects received drug. Single arm. | Drug: Duloxetine<br>* Single dose of 60 mg of duloxetine<br>* Other names: Cymbalta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender. | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 | 
| Tmax | Time to maximum plasma concentration | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 | 
| AUCo-inf, | Area under the plasma concentration time curve | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 | 
| T1/2 | Half life | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emesis | episodes of emesis. | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Bypass, Duloxetine, Cymbalta, Pharmacokinetics