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

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ClinicalTrials.gov Identifier: NCT03070509
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
Shire
Neuropsychiatric Research Institute, Fargo, North Dakota
Information provided by (Responsible Party):
Kristine Steffen, North Dakota State University

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.

Condition or disease Intervention/treatment Phase
Lisdexamfetamine Drug: Lisdexamfetamine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics of Lisdexamfetamine (Vyvanse®) in Post-bariatric Surgery Patients
Actual Study Start Date : May 12, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Area Under the Plasma Concentration Time Curve (AUC) of lisdexamfetamine [ Time Frame: 24 hour collection ]
    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.


Secondary Outcome Measures :
  1. Maximum Concentration (Cmax) of lisdexamfetamine [ Time Frame: 24 hour collection ]
    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.

  2. Time to Maximum Concentration (Tmax) of lisdexamfetamine [ Time Frame: 24 hour collection ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070509


Contacts
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Contact: Kristine Steffen, PharmD., Ph.D 701-365-4915 ksteffen@nrifargo.com
Contact: Carrie Nelson, BSN 701-365-4918 cnelson@nrifargo.com

Locations
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United States, North Dakota
Neuropsychiatric Research Institute Recruiting
Fargo, North Dakota, United States, 58103
Contact: Brian Peterson         
Principal Investigator: Kristine Steffen         
Sponsors and Collaborators
North Dakota State University
Shire
Neuropsychiatric Research Institute, Fargo, North Dakota

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Responsible Party: Kristine Steffen, Associate Professor, North Dakota State University
ClinicalTrials.gov Identifier: NCT03070509     History of Changes
Other Study ID Numbers: LIS-XXX
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents