Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

June 1, 2017 updated by: The Netherlands Cancer Institute

Pharmacokinetics of New Dexamphetamine Sustained Release Tablets and the Clinical Validation of Measuring Dexamphetamine in Dried Blood Spots

The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. These individuals have received this medication before in a previous trial where the pharmacodynamics were investigated. This trial will last 5 consecutive days during which blood samples will be drawn for pharmacokinetics analyses. Dried blood spots will also be collected for the clinical validation of the bioanalytical method wherein these are used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have completed at least 80% of the previous study (CATCH)
  • Be able and willing to participate in the study and assessments
  • Have provided written informed consent.

Exclusion Criteria:

  • Any intake of dexamphetamine 7 days or less before the start of the proposed study;
  • Contraindications for dexamphetamine
  • (desired) pregnancy or continued lactation
  • Insufficient command of the Dutch language
  • Current participation in another trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Participants receiving Dexamphetamine 60 mg SR
Drug: Dexamphetamine
Participants will receive 60 mg Dexamphetamine SR daily for 5 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the Curve (AUC) of dexamphetamine
Time Frame: Determined on the 5 day bloodsamples taken
Determined on the 5 day bloodsamples taken
Maximum plasma concentration (Cmax) of dexamphetamine
Time Frame: Determined on the 5 day bloodsamples taken
Determined on the 5 day bloodsamples taken
Half life (T 1/2) of dexamphetamine
Time Frame: Determined on the 5 day bloodsamples taken
Determined on the 5 day bloodsamples taken

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Wim van den Brink, PhD, Academic Psychiatric Center AMC-UvA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAM001DFM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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