Pharmacokinetics of Lisdexamfetamine (Vyvanse®) in Post-bariatric Surgery Patients

This study is being conducted to evaluate how the body absorbs and processes the medication lisdexamfetamine (Vyvanse®). Subjects who are 9-15 months post gastric bypass 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 one 12-hour study day and complete one 24-hour post dosing blood draw.

Study Overview

• Status: Unknown
• Conditions: Lisdexamfetamine
• Intervention / Treatment: Drug: Lisdexamfetamine

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Recruiting
      • Neuropsychiatric Research Institute
      • Contact: Brian Peterson
      • Principal Investigator: Kristine Steffen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subjects.
2. Between the ages of 18 and 60 years at the time of informed consent. *The upper age limit of 60 has been chosen as this medication carries some cardiovascular risk along with the fact that pharmacokinetics in elderly patients vary and may affect the homogeneity of the study.
3. Must be in good health as determined by physical exam, EKG, and medical history.

4a. Underwent RYGB 9-15 months prior (n=10 study completers) -or-

4b. Have not received bariatric surgery and are matched to the RYGB participants by BMI, age and sex (n= 10 study completers)

5. Women of child bearing potential must be practicing a medically acceptable method of birth control and have a negative pregnancy test at baseline.

6. No contraindications to receiving lisdexamfetamine in a single dose of 50 mg.

Exclusion Criteria:

1. Allergy to lisdexamfetamine or any of its constituents.
2. Candidates who are pregnant or nursing.
3. Candidates currently receiving a medication that interacts with lisdexamfetamine, including concurrent use of a stimulant.
4. Subjects who smoke or used any nicotine products in the last six months.
5. Subjects who have a positive urine drug screen for drugs of abuse.
6. Candidates that for any reason cannot comply with the requirements of the study procedures.
7. Candidates experiencing clinically significant or unstable neurological, hepatic, renal or cardiovascular disease on laboratory or baseline EKG screening or any medical disorder that would put the participant at increased risk in the judgement of the investigator or physician.
8. Candidates currently or with a past history of meeting diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder, or other psychotic illness.
9. Candidates with any history of drug abuse or dependence.
10. Candidates with any history of alcohol dependence, or current usage that puts the candidate at risk in the judgement of the investigator or study physician.
11. Candidates who have participated in an investigational drug study in the past 30 days.
12. Significant iron deficient anemia that may impact the pharmacokinetics of lisdexamfetamine.
13. Participant with a significantly and persistently elevated resting blood pressure (>140/90 mmHg) or pulse (>100 bpm) after repeated measurement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RYGB; Single dose of lisdexamfetamine 50 mg in RYGB patients	Drug: Lisdexamfetamine; lisdexamfetamine 50 mg single dose
Experimental: Nonsurgical Controls; Single dose of lisdexamfetamine 50 mg in non-surgical controls	Drug: Lisdexamfetamine; lisdexamfetamine 50 mg single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Plasma Concentration Time Curve (AUC) of lisdexamfetamine	The primary aim of this research is to provide a comparison of AUC associated with a single dose of lisdexamfetamine in Roux-en-Y Gastric Bypass and matched nonsurgical "control" subjects. Comparisons will be based upon lisdexamfetamine plasma concentrations obtained during the 24 hour sample collection window.	24 hour collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Concentration (Cmax) of lisdexamfetamine	We will compare the Cmax of lisdexamfetamine associated with a single dose of lisdexamfetamine in Roux-en-Y Gastric Bypass and matched nonsurgical "control" subjects. Comparisons will be based upon lisdexamfetamine plasma concentrations obtained during the 24 hour sample collection window.	24 hour collection
Time to Maximum Concentration (Tmax) of lisdexamfetamine	We will compare the Tmax of lisdexamfetamine associated with a single dose of lisdexamfetamine in Roux-en-Y Gastric Bypass and matched nonsurgical "control" subjects. Comparisons will be based upon lisdexamfetamine plasma concentrations obtained during the 24 hour sample collection window.	24 hour collection

Collaborators and Investigators

• Sponsor: North Dakota State University
• Collaborators: Shire; Neuropsychiatric Research Institute, Fargo, North Dakota

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2017
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: LIS-XXX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No