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

This study has been completed.
Sponsor:
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00919867
First received: June 10, 2009
Last updated: July 1, 2010
Last verified: July 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: SPD503
Drug: VYVANSE
Drug: SPD503 and VYVANSE
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

Primary Outcome 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919867

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

No publications provided

Responsible Party: Gerald Tremblay, MD, Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00919867     History of Changes
Other Study ID Numbers: SPD503-115
Study First Received: June 10, 2009
Results First Received: July 1, 2010
Last Updated: July 1, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Guanfacine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
 Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013