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

NCT03070509 | Unknown Phase 4 FDA Drug

• 1 other identifier: LIS-XXX
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lisdexamfetamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maximum Concentration (Cmax) of lisdexamfetamine

  24 hour collection

• Time to Maximum Concentration (Tmax) of lisdexamfetamine

  24 hour collection

Study Arms (2)

RYGB

EXPERIMENTAL

Single dose of lisdexamfetamine 50 mg in RYGB patients

Drug: Lisdexamfetamine

Nonsurgical Controls

EXPERIMENTAL

Single dose of lisdexamfetamine 50 mg in non-surgical controls

Drug: Lisdexamfetamine

Interventions

Lisdexamfetamine DRUG

lisdexamfetamine 50 mg single dose

Nonsurgical Controls; RYGB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects.
• 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.
• Must be in good health as determined by physical exam, EKG, and medical history.
• a. Underwent RYGB 9-15 months prior (n=10 study completers) -or-
• b. Have not received bariatric surgery and are matched to the RYGB participants by BMI, age and sex (n= 10 study completers)
• \. Women of child bearing potential must be practicing a medically acceptable method of birth control and have a negative pregnancy test at baseline.
• \. No contraindications to receiving lisdexamfetamine in a single dose of 50 mg.

You may not qualify if:

• Allergy to lisdexamfetamine or any of its constituents.
• Candidates who are pregnant or nursing.
• Candidates currently receiving a medication that interacts with lisdexamfetamine, including concurrent use of a stimulant.
• Subjects who smoke or used any nicotine products in the last six months.
• Subjects who have a positive urine drug screen for drugs of abuse.
• Candidates that for any reason cannot comply with the requirements of the study procedures.
• 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.
• Candidates currently or with a past history of meeting diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder, or other psychotic illness.
• Candidates with any history of drug abuse or dependence.
• 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.
• Candidates who have participated in an investigational drug study in the past 30 days.
• Significant iron deficient anemia that may impact the pharmacokinetics of lisdexamfetamine.
• Participant with a significantly and persistently elevated resting blood pressure (\>140/90 mmHg) or pulse (\>100 bpm) after repeated measurement.

Sponsors & Collaborators

• North Dakota State University: lead
• Shire: collaborator
• Neuropsychiatric Research Institute, Fargo, North Dakota: collaborator

Study Sites (1)

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

RECRUITING

MeSH Terms

Interventions

Lisdexamfetamine Dimesylate

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Central Study Contacts

Kristine Steffen, PharmD., Ph.D

CONTACT

701-365-4915; ksteffen@nrifargo.com

Carrie Nelson, BSN

CONTACT

701-365-4918; cnelson@nrifargo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: May 12, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)