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Study Examining Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults

NCT00302393 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-10-22

No results posted yet for this study

Summary

There are two specific aims of this study. The first is to document the pharmacokinetics of dopamine transporter (DAT) receptor occupancy of repeated administration of orally administered, therapeutic doses of a short immediate release-methylphenidate hydrochloride (IR-MPH) and a long-acting formulation of MPH (OROS-MPH) using positron emission tomography (PET) scanning with C-11 altropane as the ligand. The investigators hypothesize that central nervous system (CNS) DAT occupancy of the OROS-MPH to IR-MPH sequence will be greater than that of IR-MPH to OROS-MPH sequence at 5 hours after the initial administration and that the CNS DAT occupancy of the other two formulations will be intermediate.

The second aim of this study is to assess whether the abuse liability potential of delayed, repeated administrations of different formulations of MPH is moderated by the oral delivery system in which a delivery system with slower onset may be safer than one with more rapid early release.

Conditions

  • Healthy

Interventions

DRUG

OROS methylphenidate hydrochloride

Subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4 at each of the four treatment days in a crossover fashion, so that each subject will have received doses of each combination of treatments during the study. Each dose of OROS MPH will be 36 mg which will be supplied as one 36 mg capsules. Study treatments will be administered with water following an overnight fast of at least 8 hours.

DRUG

methylphenidate hydrochloride

Subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4 at each of the four treatment days in a crossover fashion, so that each subject will have received doses of each combination of treatments during the study. Each dose of IR MPH will be 20 mg which will be supplied as one 20 mg capsule. Study treatments will be administered with water following an overnight fast of at least 8 hours.

Sponsors & Collaborators

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Thomas Spencer, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-02-28
Completion
2008-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00302393 on ClinicalTrials.gov