A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers

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.

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

• Maximum Plasma Concentration (Cmax) of Guanfacine
  • Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
    Safety Issue?: No
• Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine
  • Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
    Safety Issue?: No
• Time of Maximum Plasma Concentration (Tmax) of Guanfacine
  • Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
    Safety Issue?: No
• Time of Plasma Half-Life(T 1/2) of Guanfacine
  • Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
    Safety Issue?: No
• Cmax of d-Amphetamine
  • Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
    Safety Issue?: No
• AUC of d-Amphetamine
  • Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
    Safety Issue?: No
• Tmax of d-Amphetamine
  • Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
    Safety Issue?: No
• T 1/2 of d-Amphetamine
  • Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
    Safety Issue?: No

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 Investigator: Shire Pharmaceutical Development Industry

Information obtained from ClinicalTrials.gov on February 02, 2012

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