Effects of Gastric Bypass on Blood Levels of Duloxetine

This study has been completed.
Sponsor:
Collaborators:
University of North Dakota
Eli Lilly and Company
Information provided by (Responsible Party):
James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier:
NCT00989157
First received: October 1, 2009
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Bariatric Surgery
Drug: Duloxetine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine

Resource links provided by NLM:


Further study details as provided by Neuropsychiatric Research Institute, Fargo, North Dakota:

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 ]
    Half life


Secondary Outcome Measures:
  • Emesis [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
    episodes of emesis.


Enrollment: 20
Study Start Date: September 2009
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active drug
All subjects received drug. Single arm.
Drug: Duloxetine
Single dose of 60 mg of duloxetine
Other Name: Cymbalta

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989157

Locations
United States, North Dakota
Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
Neuropsychiatric Research Institute, Fargo, North Dakota
University of North Dakota
Eli Lilly and Company
Investigators
Principal Investigator: James L Roerig, PharmD, BCPP Neuropsychiatric Research Institute and University of North Dakota
  More Information

Additional Information:
No publications provided

Responsible Party: James Roerig, James L Roerig, PharmD, BCPP, Neuropsychiatric Research Institute and University of North Dakota, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier: NCT00989157     History of Changes
Other Study ID Numbers: F1J-US-X054
Study First Received: October 1, 2009
Results First Received: April 8, 2014
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Neuropsychiatric Research Institute, Fargo, North Dakota:
Gastric Bypass
Duloxetine
Cymbalta
Pharmacokinetics

Additional relevant MeSH terms:
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on October 01, 2014