A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine
Overview
- Phase
- Phase 3
- Intervention
- Duloxetine
- Conditions
- Bariatric Surgery
- Sponsor
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
James Roerig
James L Roerig, PharmD, BCPP, Neuropsychiatric Research Institute and University of North Dakota
Neuropsychiatric Research Institute, Fargo, North Dakota
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.
Arms & Interventions
Active drug
All subjects received drug. Single arm.
Intervention: Duloxetine
Outcomes
Primary Outcomes
Cmax
Time Frame: 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
Time Frame: 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,
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- Emesis(4 days)