Effects of Gastric Bypass on Blood Levels of Duloxetine

NCT00989157 | Completed Phase 3 Results

• 1 other identifier: F1J-US-X054
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery

Keywords

Gastric Bypass; Duloxetine; Cymbalta; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Emesis

  4 days

Study Arms (1)

Active drug

EXPERIMENTAL

All subjects received drug. Single arm.

Drug: Duloxetine

Interventions

Duloxetine DRUG

Single dose of 60 mg of duloxetine

Also known as: Cymbalta

Active drug

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuropsychiatric Research Institute, Fargo, North Dakota: lead
• University of North Dakota: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

Location

Related Links

• Neuropsychiatric Research Institute

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. James Roerig
• Organization: NRIFargo

jroerig@nrifargo.com

701 365 4919

Study Officials

• James L Roerig, PharmD, BCPP

  Neuropsychiatric Research Institute and University of North Dakota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James L Roerig, PharmD, BCPP, Neuropsychiatric Research Institute and University of North Dakota

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 11, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-07

Locations

US (1)