Venlafaxine PK Following Bariatric Surgery

Sleeve Gastrectomy Clinical Trial

— VLX  

Official title:

A Comparison of Immediate and Extended Release Venlafaxine Following Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005107
• Other study ID #: KSteffenVLX
• Secondary ID: EPSCOR
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2013
• Last updated: April 4, 2016
• Start date: December 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2016
• Source: North Dakota State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Roux en Y Gastric Bypass
• Sleeve Gastrectomy

Intervention

Drug:
• Venlafaxine IR and Venlafaxine XR

Locations

Country	Name	City	State
United States	Neuropsychiatric Research Institute	Fargo	North Dakota

Sponsors (2)

Lead Sponsor	Collaborator
North Dakota State University	Neuropsychiatric Research Institute, Fargo, North Dakota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary PK Characteristics (Composite)	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.	24 hour collection	No

External Links

•   Neuropsychiatric Research Institute Website