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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00901576
First received: May 12, 2009
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.


Condition Intervention Phase
Healthy
Drug: SPD503
Drug: Concerta
Drug: SPD503 + Concerta
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 CONCERTA, Administered Alone and in Combination in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by Shire:

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-Methylphenidate [ 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-Methylphenidate [ 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-Methylphenidate [ 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-Methylphenidate [ 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: 38
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD503 Drug: SPD503
SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets
Other Name: Intuniv
Active Comparator: Concerta Drug: Concerta
CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.
Active Comparator: SPD503 + Concerta Drug: SPD503 + Concerta
SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).

  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 the screening visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901576

Locations
United States, New Jersey
Advanced Biomedical Research, Inc.
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Shire
  More Information

Additional Information:
Publications:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00901576     History of Changes
Other Study ID Numbers: SPD503-114
Study First Received: May 12, 2009
Results First Received: April 16, 2010
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Healthy volunteers

Additional relevant MeSH terms:
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014