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| Name | Class |
|---|---|
| Shire | INDUSTRY |
| Neuropsychiatric Research Institute, Fargo, North Dakota | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RYGB | Experimental | Single dose of lisdexamfetamine 50 mg in RYGB patients |
|
| Nonsurgical Controls | Experimental | Single dose of lisdexamfetamine 50 mg in non-surgical controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine | Drug | lisdexamfetamine 50 mg single dose |
|
| 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 |
| 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 |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristine Steffen, PharmD., Ph.D | Contact | 701-365-4915 | ksteffen@nrifargo.com | |
| Carrie Nelson, BSN | Contact | 701-365-4918 | cnelson@nrifargo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychiatric Research Institute | Recruiting | Fargo | North Dakota | 58103 | United States |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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| 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 |
| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |