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An Open Label Phase I/II Study of Dopamine Transporter Receptor Occupancy With OROS and Immediate Release Methylphenidate as Measured With C-11 Altropane in Human Subjects

This study has been completed.
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00302367
First received: March 10, 2006
Last updated: July 11, 2011
Last verified: July 2011
History of Changes
  Purpose

The specific aim of this study is to document the pharmacokinetics of DAT receptor occupancy of OROS and immediate release (IR) MPH using PET scanning with C-11 altropane as the ligand. We hypothesize that the time to maximal receptor occupancy and the degree of receptor occupancy of immediate release (IR) MPH will be shorter and greater (respectively) than with an equipotent dose of OROS MPH.


Condition Intervention Phase
Healthy Volunteers
 Drug: OROS methylphenidate hydrochloride
Drug: immediate release methylphenidate hydrochloride
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: An Open Label Phase I/II Study of Dopamine Transporter Receptor Occupancy With OROS and Immediate Release Methylphenidate as Measured With C-11 Altropane in Human Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The DAT receptor occupancy of OROS MPH and Metadate CD using PET scanning with C-11 Altropane. Objective measures also provided by d and l ritalinic acid and methylphenidate levels at pre-dose through hour 10.

Estimated Enrollment: 20
Study Start Date: January 2004
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Detailed Description:

This protocol seeks to document the pharmacokinetics of DAT receptor occupancy of OROS and immediate release (IR) MPH using PET and C-11 altropane. 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). This research will provide novel and unique information toward a better understanding of the mechanism of action of long-acting stimulant formulations to enable new drug development and an estimation of the relative abuse potential of the current formulation.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed written informed consent to participate in the study.
  2. Age: 18 - 55
  3. If female, non-pregnant, non-nursing with a negative serum pregnancy test and using an adequate form of birth control.
  4. Supine and standing blood pressure within the range 110/60 to 150/90 mmHg.
  5. Heart rate, after resting for 5 minutes, within the range 46-90 beats/min.
  6. Subjects who are within 20% of the ideal weight for height as
  7. Right handed.

Exclusion Criteria:

  1. Diagnosis of any psychotic disorder, bipolar disorder, severe depression, severe anxiety, or Autism. Subjects with mild mood, oppositional, conduct, and anxiety disorders may be permitted to participate if considered appropriate by the investigator.

  2. Scores of Baseline Scales:

    Hamilton Depression Scale > 17 (out of a possible 67 on the 21-item scale)[18] Beck Depression Inventory > 19 (out of a possible 63 on the 21-item scale)[19] Hamilton Anxiety Scale > 21 (out of a possible 56 on the 14-item scale) [20]

  3. Tics or Tourette's Syndrome.
  4. History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention.
  5. Any clinically significant chronic medical condition, in the judgment of the investigator.
  6. Mental impairment as evidenced by an I.Q. <75.
  7. Exposure to dopamine receptor antagonists within the previous three (3) months.
  8. Exposure to radiopharmaceuticals within four (4) weeks prior to PET scan.
  9. Subjects receiving psychotropic medication.
  10. Any clinically significant abnormality in the screening laboratory tests, vital signs, or 11-lead ECG, outside of normal limits.

12. Any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant.

13. Subjects with a known recent history (within the past six (6) months) of illicit drug or alcohol dependence

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302367

Locations
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Principal Investigator: Thomas Spencer, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Thomas J. Spencer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00302367     History of Changes
Other Study ID Numbers: 2003-p-002058
Study First Received: March 10, 2006
Last Updated: July 11, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013