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

NCT ID: NCT00302367

Last Updated: 2011-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2004-04-30

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.

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Interventions

OROS methylphenidate hydrochloride

Intervention Type: DRUG

immediate release methylphenidate hydrochloride

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Massachusetts General Hospital

Principal Investigators

Thomas Spencer, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

2003-p-002058

Identifier Type: -

Identifier Source: org_study_id