Effects of Gastric Bypass on Blood Levels of Duloxetine

A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery
• Intervention / Treatment: Drug: Duloxetine

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Neuropsychiatric Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active drug; All subjects received drug. Single arm.	Drug: Duloxetine; Single dose of 60 mg of duloxetine; Other Names: Cymbalta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	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.	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
Tmax	Time to maximum plasma concentration	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
AUCo-inf,	Area under the plasma concentration time curve	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
T1/2	Half life	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emesis	episodes of emesis.	4 days

Collaborators and Investigators

• Sponsor: Neuropsychiatric Research Institute, Fargo, North Dakota
• Collaborators: Eli Lilly and Company; University of North Dakota
• Investigators: Principal Investigator: James L Roerig, PharmD, BCPP, Neuropsychiatric Research Institute and University of North Dakota

Publications and helpful links

Helpful Links

• Neuropsychiatric Research Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: October 1, 2009
• First Submitted That Met QC Criteria: October 1, 2009
• First Posted (Estimate): October 2, 2009

Study Record Updates

• Last Update Posted (Estimate): August 11, 2014
• Last Update Submitted That Met QC Criteria: July 17, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Duloxetine; Gastric Bypass; Cymbalta
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: F1J-US-X054