Official Title: “A Phase 1, Open-label, Randomized, Three-period Crossover Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD503 and VYVANSE, Administered Alone and in Combination in Healthy Adult Volunteers”

Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: SPD503
  • SPD503 extended-release 4mg orally administered tablets. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.
• Drug: VYVANSE
  • VYVANSE 50mg orally administered capsules. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.
• Drug: SPD503 and VYVANSE
  • SPD503 4mg tablets + VYVANSE 50mg capsules orally administered together. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A: SPD503 (4mg)
• Active Comparator: B: VYVANSE (50mg)
• Active Comparator: C: SPD503 (4mg) + VYVANSE (50mg)

Primary Measures

• pharmacokinetic parameters will be determined from the plasma concentration-time data for guanfacine and d-amphetamine following single dose administration of SPD503 and VYVANSE each alone as well as in combination
  • Time Frame: 12 days (total confinement)
    Safety Issue?: No

Secondary Measures

• vital signs (blood pressure, pulse); ECG findings; physical exam findings, and clinical safety lab parameters
  • Time Frame: 12 days (total confinement)
    Safety Issue?: Yes

Inclusion Criteria:

• Subjects must be normal healthy adult volunteers (with no significant abnormalities in medical history, physical exam, vital signs or lab evaluations at screening) in order to be eligible to participate.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Shire Pharmaceutical Development

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00919867

Study ID Number: SPD503-115

ClinicalTrials.gov Identifier: NCT00919867

Health Authority: United States: Food and Drug Administration