Venlafaxine PK Following Bariatric 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; Sleeve Gastrectomy
Intervention: Venlafaxine IR and Venlafaxine XR (Drug)
Phase: Phase 4
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: North Dakota State University & Neuropsychiatric Research Institute
Summary
This study is being conducted to evaluate how the body absorbs and processes the immediate
release (IR) and sustained release (XR) medication venlafaxine (EffexorŽ). 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.
Clinical Details
Official title: A Comparison of Immediate and Extended Release Venlafaxine Following Bariatric Surgery
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Venlafaxine Plasma Concentrations/Area-Under-the-Curve (AUC)
Secondary outcome: Secondary PK Characteristics (Composite)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or Female
2. Age 18-65 (inclusive, at time of informed consent)
3. No tobacco use in the past three months.
4. 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.
5. Ability to read, write and understand English
Exclusion Criteria:
1. Taking a medication that has a clinically significant interaction with venlafaxine or
an interaction that may alter the study data.
2. Hypersensitivity to venlafaxine or any excipient contained within the dosage forms
3. Inability to tolerate repeated blood draws.
4. Any history of bipoloar disorder or a psychotic disorder.
5. Current major depressive disorder or current suicidality.
6. Alcohol or substance dependence in the past year.
7. Currently pregnant or lactating or unwillingness to use medically accepted
contraception during study
8. 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).
9. Medical conditon which may increase participant risk with venlafaxine or uncontrolled
hypertension at the discretion of the examining provider.
10. 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.
11. 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.
12. Poor or ultra-rapid Cytochrome P450 2D6 metabolizer.
13. Self reported history of viral hepatits or HIV.
14. Positive urine drug screen unless documented prescription of a non-interacting
medication.
Locations and Contacts
Neuropsychiatric Research Institute, Fargo, North Dakota 58103, United States
Additional Information
Neuropsychiatric Research Institute Website
Starting date: December 2013
Last updated: May 8, 2015
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