Venlafaxine PK Following Bariatric Surgery

NCT02005107 | Completed Phase 4

• 2 other identifiers: KSteffenVLXEPSCOR
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to evaluate how the body absorbs and processes the immediate release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are 1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete two 12-hour study days approximately 11 days apart. This study will enroll up to 30 participants.

Conditions

Roux en Y Gastric Bypass; Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

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

  The primary aim of this research is to provide a comparison of pharmacokinetic measures associated with a single dose of venlafaxine IR (immediate release) and venlafaxine XR (sustained release) in Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, and matched nonsurgical "control" subjects. Comparisons will be based upon venlafaxine plasma concentrations obtained during the 24 hour sample collection window.

  24 hours intervals

Secondary Outcomes (1)

• Secondary PK Characteristics (Composite)

  24 hour collection

Study Arms (2)

venlafaxine

EXPERIMENTAL

Venlafaxine IR and XR, single dosages of each separated by a wash-out period

Drug: Venlafaxine IR and Venlafaxine XR

Venlafaxine XR and Venlafaxine IR

OTHER

Each participant (3 groups of participants) will receive one dose of venlafaxine IR and one dose of venlafaxine XR seperated by a wash-out period.

Drug: Venlafaxine IR and Venlafaxine XR

Interventions

Venlafaxine IR and Venlafaxine XR DRUG

Also known as: Effexor and Effexor XR

Venlafaxine XR and Venlafaxine IR; venlafaxine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• Age 18-65 (inclusive, at time of informed consent)
• No tobacco use in the past three months.
• Underwent Roux-en-Y Gastric Bypass or Sleeve Gastrectomy weight loss surgery 12-36 months prior to study OR has not had a weight loss surgery but matches the gastric bypass patients on age, gender, and BMI. Criteria for matching will be established at the beginning of the study in consultation with the statistical team and addressed as needed with the input of the biostatistician.
• Ability to read, write and understand English

You may not qualify if:

• Taking a medication that has a clinically significant interaction with venlafaxine or an interaction that may alter the study data.
• Hypersensitivity to venlafaxine or any excipient contained within the dosage forms
• Inability to tolerate repeated blood draws.
• Any history of bipoloar disorder or a psychotic disorder.
• Current major depressive disorder or current suicidality.
• Alcohol or substance dependence in the past year.
• Currently pregnant or lactating or unwillingness to use medically accepted contraception during study
• Taking a medication which significantly alters gastrointesinal transit time or significantly reduces acid secretion (e.g. routine use of proton pump inhibitors, H2 antagonists, sucralfate).
• Medical conditon which may increase participant risk with venlafaxine or uncontrolled hypertension at the discretion of the examining provider.
• Hepatic insufficiency as defined by any hepatic enzyme greater than 3x the upper limit of normal or other hepatic laboratory abnormalities at the discretion of the medical provider.
• Renal impairment as evidence by a calculated creatinine clearance of less than or equal to 70ml/min or other abnormality on a renal panel that the medical provider feels puts the participant at risk.
• Poor or ultra-rapid Cytochrome P450 2D6 metabolizer.
• Self reported history of viral hepatits or HIV.
• Positive urine drug screen unless documented prescription of a non-interacting medication.

Sponsors & Collaborators

• North Dakota State University: lead
• Neuropsychiatric Research Institute, Fargo, North Dakota: collaborator

Study Sites (1)

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

Location

Related Links

• Neuropsychiatric Research Institute Website

MeSH Terms

Interventions

Venlafaxine Hydrochloride

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Kristine J Steffen, Pharm.D., Ph.D.

  North Dakota State University & Neuropsychiatric Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, North Dakota State University

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

US (1)