Effects of Gastric Bypass on Blood Levels of Duloxetine

Bariatric Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989157
• Other study ID #: F1J-US-X054
• Status: Completed
• Phase: Phase 3
• First received: October 1, 2009
• Last updated: July 17, 2014
• Start date: September 2009
• Est. completion date: November 2012

Study information

• Verified date: July 2014
• Source: Neuropsychiatric Research Institute, Fargo, North Dakota
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Drug:
• Duloxetine
Single dose of 60 mg of duloxetine

Locations

Country	Name	City	State
United States	Neuropsychiatric Research Institute	Fargo	North Dakota

Sponsors (3)

Lead Sponsor	Collaborator
Neuropsychiatric Research Institute, Fargo, North Dakota	Eli Lilly and Company, University of North Dakota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Emesis	episodes of emesis.	4 days	Yes

External Links

•   Neuropsychiatric Research Institute