Effects of Gastric Bypass on Blood Levels of Duloxetine

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Active drug	Duloxetine	All subjects received drug. Single arm.

Primary Outcome Measures

Name	Time	Method
Cmax	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	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.
Tmax	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	Time to maximum plasma concentration
AUCo-inf,	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	Area under the plasma concentration time curve
T1/2	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	Half life