Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Treatments: Dextroamphetamine

Criteria

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