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Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery

Information source: North Dakota State University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Roux en Y Gastric Bypass Surgery

Intervention: Sertraline (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: North Dakota State University

Official(s) and/or principal investigator(s):
Kristine J Steffen, Pharm.D., Ph.D., Principal Investigator, Affiliation: Neuropsychiatric Research Institute

Summary

This study is being conducted to evaluate how the body absorbs and processes the medication sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric bypass surgery. Participants will be asked to take part in this study at three time points: 1) before their bariatric surgery, 2) at three months following the surgery, and 3) twelve months following surgery. This study will enroll approximately 30 participants.

Clinical Details

Official title: A Prospective, Longitudinal Comparison of the Pharmacokinetic Properties of Sertraline Before and After Roux-en-Y Gastric Bypass

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Sertraline Plasma Concentrations/Area-Under-the-Curve (AUC)

Secondary outcome:

Bioavailability comparison between sertraline tablet and sertraline liquid

Body Composition and Weight

Hepatic Function

Plasma Protein Concentrations

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 1. Male or female between 18 and 60 years of age at the time of Informed Consent

- 2. Scheduled to undergo Roux en Y Gastric Bypass Surgery (RYGBP) or in evaluation for

surgery prior to scheduling at the investigators' discretion.

- 3. Ability to swallow whole medication tablets and eat solid foods

Exclusion Criteria:

- 1. Those taking any medication at the time of the study which has a known, clinically

significant, drug-interaction with sertraline, which may affect participant safety or threaten the validity of the data.

- 2. Hypersensitivity to sertraline or any excipient contained in either the tablet or

solution

- 3. Inability to tolerate blood draws

- 4. History of or current bipolar disorder, psychotic disorder, or current major

depressive disorder or suicidality, or other psychiatric condition that the investigator feels may put the subject at additional risk by participating in the study

- 5. Alcohol or other substance abuse in the past four weeks or dependence in the past

year

- 6. Currently pregnant or lactating or any participant who wants to become pregnant

during the study

- 7. Female participant unwilling to use an accepted method of birth control during

the study assessment periods.

- 8. Disulfiram or metronidazole at baseline (due to small percentage of alcohol in

sertraline solution) or other medication with a similar interaction with a very small amount of alcohol

- 9. Inability or unwillingness to avoid alcohol or grapefruit juice for the required

study duration

- 10. Baseline medications which significantly alter gastrointestinal transit time

(e. g. oral anticholinergic medications, metoclopramide, erythromycin) and are taken on a routinely scheduled basis. In addition, any such medication cannot be taken in close proximity (minimum of five half-lives of the drug) to the study sertraline administration.

- 11. Medical condition which may increase participant risk with sertraline

- 12. Hepatic insufficiency (Hepatic insufficiency will be defined as any liver enzyme

test on a standard hepatic panel of greater than or equal to twice the upper limit of normal, or any other hepatic abnormality identified on physical exam, self-report, or laboratory testing that puts the participant at risk in the opinion of the study physician or physician assistant.)

- 13. History of daily tobacco product use in the past six months

- 14. Participants who have undergone any type of prior surgical procedure for weight

loss

- 15. Significant Latex allergy (liquid form has a latex dropper)

- 16. Participant employed by, or who has immediate family employed by NRI

- 17. History of Hepatitis or HIV Infection

Locations and Contacts

Neuropsychiatric Research Institute, Fargo, North Dakota 58103, United States
Additional Information

Neuropsychiatric Research Institute Website

Starting date: October 2010
Last updated: May 8, 2015

Page last updated: August 23, 2015

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