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A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults

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ClinicalTrials.gov Identifier: NCT00301639
Recruitment Status : Completed
First Posted : March 13, 2006
Last Update Posted : July 12, 2011
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:
Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE March 10, 2006
First Posted Date  ICMJE March 13, 2006
Last Update Posted Date July 12, 2011
Study Start Date  ICMJE March 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2006)
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, hr 9, 10 and 11.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults
Official Title  ICMJE A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: OROS methylphenidate hydrochloride
  • Drug: methylphenidate hydrochloride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March 10, 2006)
40
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed written informed consent to participate in the study.
  2. Age: 18 - 55
  3. If female, non-pregnant, non-nursing, using an adequate form of birth control or a negative serum pregnancy test.
  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.
  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) (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)

  3. Tics or Tourette's Syndrome.
  4. Diagnosis of ADHD
  5. History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention.
  6. Any clinically significant chronic medical condition, in the judgment of the investigator.
  7. Mental impairment as evidenced by an I.Q. <75.
  8. Exposure to dopamine receptor antagonists within the previous three (3) months.
  9. Exposure to radiopharmaceuticals within four (4) weeks prior to PET scan.
  10. Subjects receiving psychotropic medication.
  11. Any clinically significant abnormality in the screening laboratory tests, vital signs, or 12-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.
  14. Subjects diagnosed with glaucoma.
  15. Subjects at risk for MPH toxicity (e.g. individuals with arrhythmias, coronary artery disease, etc.).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00301639
Other Study ID Numbers  ICMJE 2004-p-002189
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas J. Spencer, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators  ICMJE
Principal Investigator: Thomas Spencer, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP