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

NCT00302367 | Completed Phase 4

• 1 other identifier: 2003-p-002058
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

OROS methylphenidate hydrochloride DRUG

immediate release methylphenidate hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• 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) \[20\]
• Tics or Tourette's Syndrome.
• History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention.
• Any clinically significant chronic medical condition, in the judgment of the investigator.
• Mental impairment as evidenced by an I.Q. \<75.
• Exposure to dopamine receptor antagonists within the previous three (3) months.
• Exposure to radiopharmaceuticals within four (4) weeks prior to PET scan.
• Subjects receiving psychotropic medication.
• Any clinically significant abnormality in the screening laboratory tests, vital signs, or 11-lead ECG, outside of normal limits.
• \. Any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant.
• \. Subjects with a known recent history (within the past six (6) months) of illicit drug or alcohol dependence

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

Study Officials

• Thomas Spencer, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 14, 2006
• Study Start: January 1, 2004
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: July 12, 2011

Record last verified: 2011-07

Locations

US (1)