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Completed

NCT Number: NCT02005107

Venlafaxine PK Following Bariatric Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Venlafaxine IR and Venlafaxine XR

Drug

Other names: Effexor and Effexor XR

Primary outcomes

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

    Time frame: 24 hours intervals

    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.

Secondary outcomes

  1. Secondary PK Characteristics (Composite)

    Time frame: 24 hour collection

    We will also evaluate other PK characteristics associated with venlafaxine, such as Cmax, Tmax, t1/2, and the ratio of venlafaxine to the active metabolite ODV, and others.

Sponsors and collaborators

Lead sponsor

North Dakota State University

Other

Collaborators

  • Neuropsychiatric Research Institute, Fargo, North Dakota

Registry information

Official study title

A Comparison of Immediate and Extended Release Venlafaxine Following Bariatric Surgery

Acronym: VLX

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2013
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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