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Sponsors and Collaborators: |
Massachusetts General Hospital McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00301639 |
The specific aim of this study is to document the pharmacokinetics of dopamine transporter DAT receptor occupancy of OROS MPH and Metadate CD using PET scanning with C-11 Altropane as the ligand. We hypothesize that CNS DAT occupancy of OROS MPH will be greater than that of Metadate CD at 10 hours after administration.
Condition | Intervention | Phase |
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Healthy Volunteers |
Drug: OROS methylphenidate hydrochloride Drug: methylphenidate hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Historical Control, Crossover Assignment |
Official Title: | A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults |
Estimated Enrollment: | 40 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | December 2005 |
OROS-MPH’s pharmacokinetic profile uses an increasing delivery of MPH over the day (ascending pharmacokinetic curve). It was designed to replace IR-MPH TID treatment. Another new long-acting formulation is Metadate CD. Metadate CD consists of capsules with two types of beads. It was designed to replace IR-MPH BID treatment. The main target of MPH in the brain is the dopamine transporter (DAT). We have an exquisitely sensitive methodology to measure DAT occupancy using C-11 Altropane and Positron Emission Tomography (PET). The time course of decay of the C-11 Altropane permits repeated imaging, thus allowing documentation of the pharmacokinetics of DAT receptor occupancy.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Scores of Baseline Scales:
Hamilton Depression Scale > 17 (out of a possible 67 on the 21-item scale) (Hamilton 1960) Beck Depression Inventory > 19 (out of a possible 63 on the 21-item scale) (Beck et al 1961) Hamilton Anxiety Scale > 21 (out of a possible 56 on the 14-item scale) (Hamilton 1959)
United States, Massachusetts | |
Massachusetts General Hospital | |
Cambridge, Massachusetts, United States, 02138 |
Principal Investigator: | Thomas Spencer, MD | Massachusetts General Hospital |
Study ID Numbers: | 2004-p-002189 |
Study First Received: | March 10, 2006 |
Last Updated: | March 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00301639 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dopamine Uptake Inhibitors Neurotransmitter Agents Dopamine Methylphenidate |
Central Nervous System Stimulants Dopamine Agents Healthy |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Methylphenidate Central Nervous System Stimulants Dopamine Agents Central Nervous System Agents Pharmacologic Actions |