Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery

NCT01214382 | Completed Phase 3 DMC

• 1 other identifier: 1K23DK085066-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Roux en Y Gastric Bypass Surgery

Keywords

Gastric Bypass; Bariatric Surgery; Sertraline; Zoloft; Pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• Sertraline Plasma Concentrations/Area-Under-the-Curve (AUC)

  The primary aim of this research is to provide a prospective, longitudinal comparison of pharmacokinetic measures associated with a single-dose of sertraline in RYGBP patients. Comparisons will be based upon sertraline plasma concentrations obtained prior to surgery and repeated at three and 12 months following surgery. A 24+ month post-surgery follow-up to evaluate sertraline tablet AUC will be offered to a subset of study volunteers.

  72 hour intervals

Secondary Outcomes (4)

• Bioavailability comparison between sertraline tablet and sertraline liquid

  72 hours

• Body Composition and Weight

  72 hours

• Hepatic Function

  72 hours

• Plasma Protein Concentrations

  72 hours

Study Arms (1)

Sertraline

EXPERIMENTAL

Drug: Sertraline

Interventions

Sertraline DRUG

Single dose sertraline 100 mg, tablet and solution

Also known as: Zoloft

Sertraline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Male or female between 18 and 60 years of age at the time of Informed Consent
• \. Scheduled to undergo Roux en Y Gastric Bypass Surgery (RYGBP) or in evaluation for surgery prior to scheduling at the investigators' discretion.
• \. Ability to swallow whole medication tablets and eat solid foods

You may not qualify if:

• \. 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.
• \. Hypersensitivity to sertraline or any excipient contained in either the tablet or solution
• \. Inability to tolerate blood draws
• \. 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
• \. Alcohol or other substance abuse in the past four weeks or dependence in the past year
• \. Currently pregnant or lactating or any participant who wants to become pregnant during the study
• \. Female participant unwilling to use an accepted method of birth control during the study assessment periods.
• \. 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
• \. Inability or unwillingness to avoid alcohol or grapefruit juice for the required study duration
• \. 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.
• \. Medical condition which may increase participant risk with sertraline
• \. 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.)
• \. History of daily tobacco product use in the past six months
• \. Participants who have undergone any type of prior surgical procedure for weight loss
• \. Significant Latex allergy (liquid form has a latex dropper)

Sponsors & Collaborators

• North Dakota State University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

Location

Related Links

• Neuropsychiatric Research Institute Website

MeSH Terms

Interventions

Sertraline

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Kristine J Steffen, Pharm.D., Ph.D.

  Neuropsychiatric Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, North Dakota State University

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 5, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

US (1)