Clinical trial NCT00989157: Effects of Gastric Bypass on Blood Levels of Duloxetine
Official title: A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bariatric Surgery
Keywords: Gastric Bypass
Duloxetine
Cymbalta
Pharmacokinetics
Lead sponsor: Neuropsychiatric Research Institute, Fargo, North Dakota
Sponsor class: OTHER
Collaborators: name: University of North Dakota
name: Eli Lilly and Company
First posted: 2009-10-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cmax
timeFrame: 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
measure: Tmax
timeFrame: 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
measure: AUCo-inf,
timeFrame: 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
measure: T1/2
timeFrame: 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 outcomes:
measure: Emesis
timeFrame: 4 days
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Neuropsychiatric Research Institute
state: North Dakota
Study officials:
affiliation: Neuropsychiatric Research Institute and University of North Dakota
name: James L Roerig, PharmD, BCPP
role: PRINCIPAL_INVESTIGATOR
References: