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

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ClinicalTrials.gov Identifier: NCT00919867
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : August 2, 2010
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

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

Condition or disease Intervention/treatment Phase
Healthy Drug: SPD503 Drug: VYVANSE Drug: SPD503 and VYVANSE Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : July 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A: SPD503 (4mg) 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.
Other Name: guanfacine hydrochloride
Active Comparator: B: VYVANSE (50mg) 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.
Other Name: lisdexamfatamine dimesylate (LDX)
Active Comparator: C: SPD503 (4mg) + VYVANSE (50mg) 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.



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT00919867


Locations
United States, New Jersey
Advanced Biomedical Research, Inc.
Hackensack, New Jersey, United States
Sponsors and Collaborators
Shire

Publications of Results:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00919867     History of Changes
Other Study ID Numbers: SPD503-115
First Posted: June 12, 2009    Key Record Dates
Results First Posted: August 2, 2010
Last Update Posted: February 6, 2014
Last Verified: January 2014

Keywords provided by Shire:
Normal, healthy volunteers (for this Phase 1 study)

Additional relevant MeSH terms:
Lisdexamfetamine Dimesylate
Guanfacine
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
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents