VLX: Venlafaxine PK Following Bariatric Surgery

• Sponsor: North Dakota State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02005107
• Collaborator: Neuropsychiatric Research Institute, Fargo, North Dakota (Other)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 14.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Roux en Y Gastric Bypass; Sleeve Gastrectomy	Drug: Venlafaxine IR and Venlafaxine XR	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Comparison of Immediate and Extended Release Venlafaxine Following Bariatric Surgery
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: venlafaxine Venlafaxine IR and XR, single dosages of each separated by a wash-out period	Drug: Venlafaxine IR and Venlafaxine XR; Other Names: Effexor and Effexor XR
Other: Venlafaxine XR and Venlafaxine IR 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; Other Names: Effexor and Effexor XR

Outcome Measures

Primary Outcome Measures

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

1. Secondary PK Characteristics (Composite) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neuropsychiatric Research Institute	Fargo	North Dakota	United States	58103

Sponsors and Collaborators

• North Dakota State University
• Neuropsychiatric Research Institute, Fargo, North Dakota

Investigators

• Principal Investigator: Kristine J Steffen, Pharm.D., Ph.D., North Dakota State University & Neuropsychiatric Research Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Neuropsychiatric Research Institute Website

Publications

None provided.

• Responsible Party: Kristine Steffen, Associate Professor, North Dakota State University, North Dakota State University
• ClinicalTrials.gov Identifier: NCT02005107
• Other Study ID Numbers: KSteffenVLX; EPSCOR
• First Posted: Dec 9, 2013
• Last Update Posted: Apr 6, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Venlafaxine Hydrochloride

Study Results

No Results Posted as of Apr 6, 2016