NCT00593138

A Randomized Open-label Study of Dopamine Transporter Receptor Occupancy With Long-acting Dex-methylphenidate (20 mg, 30 mg, and 40 mg) as Measured With C-11 Altropane in Healthy Adult Volunteers

Completed Phase 1/Phase 2 Last updated 21 October 2013

What this trial tests

Phase 1/Phase 2 trial testing dex-methylphenidate in Drug Binding to DAT Receptors in 23 participants. Completed in 1 December 2009.

Timeline

1 December 2006

Primary endpoint
1 December 2007

1 December 2009

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	23
Start date	1 December 2006
Primary completion	1 December 2007
Estimated completion	1 December 2009
Sites	1 location across United States

Drugs / interventions tested

• dex-methylphenidate — full drug profile →

Conditions studied

• Drug Binding to DAT Receptors — all drugs for Drug Binding to DAT Receptors →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 55, any sex, with Drug Binding to DAT Receptors. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• DAT occupancy from PET scan results
  Time frame: each study visit

Sponsor's own description

The objectives of this study are to document the pharmacokinetics of the adequacy of DAT receptor occupancy d-MPH formulation in three doses (20 mg, 30 mg, and 40 mg) using PET scanning with C-11 Altropane as the ligand across a range of times. It has been estimated that MPH is effective when the average CNS DAT occupancy is 50% or greater. Focalin XR has been shown to be clinically effective in an analog classroom as early as 1 hour and as late as 12 hours. Therefore, it is hypothesized that the average DAT occupancy will be adequate (50% or greater) at time periods corresponding to the times of clinical efficacy.

The first objective is to examine the onset of action by testing whether average DAT occupancy will be adequate (50% or greater) at 1 hour after dosing for each dose tested (20 mg, 30 mg, 40 mg).

The second objective is to test the adequacy of average DAT occupancy in a range of later times for each dose. The times chosen (8, 10 and 12 hours) correspond to times Focalin XR has been shown to be clinically effective in an analogue classroom study. A range of times have been chosen since, while effective at 12 hours, the degree of clinical effectiveness decreased with later time periods. The adequacy of DAT occupancy across this range of time periods will provide important details on the in vivo molecular action of the medicine at periods of critical clinical activity.

The third exploratory objective is to examine a time period later then those previously tested with the highest dose. Since the clinical effectiveness of Focalin XR has not been tested out to 14 hours, it is unknown whether it is effective at 14 hours. If Focalin XR were to be effective at 14 hours it would be more likely at the highest dose.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Understanding the central pharmacokinetics of spheroidal oral drug absorption system (SODAS) dexmethylphenidate: a positron emission tomography study of dopamine transporter receptor occupancy measured with C-11 altropane.
   Spencer TJ, Bonab AA, Dougherty DD, Mirto T, et al · · 2012 · cited 5× · PMID 22154896 · DOI 10.4088/jcp.10m06393