Effects of Gastric Bypass on Blood Levels of Duloxetine
This study has been completed.
University of North Dakota
Eli Lilly and Company
Information provided by (Responsible Party):
James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
First received: October 1, 2009
Last updated: July 17, 2014
Last verified: July 2014
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.
||Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
||A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Emesis [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
episodes of emesis.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
Experimental: Active drug
All subjects received drug. Single arm.
Single dose of 60 mg of duloxetine
Other Name: Cymbalta
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00989157
|Neuropsychiatric Research Institute
|Fargo, North Dakota, United States, 58103 |
Neuropsychiatric Research Institute, Fargo, North Dakota
University of North Dakota
Eli Lilly and Company
||James L Roerig, PharmD, BCPP
||Neuropsychiatric Research Institute and University of North Dakota
No publications provided
||James Roerig, James L Roerig, PharmD, BCPP, Neuropsychiatric Research Institute and University of North Dakota, Neuropsychiatric Research Institute, Fargo, North Dakota
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 1, 2009
|Results First Received:
||April 8, 2014
||July 17, 2014
||United States: Institutional Review Board
Keywords provided by Neuropsychiatric Research Institute, Fargo, North Dakota:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2014
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Dopamine Uptake Inhibitors