Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

Cocaine Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768441
• Other study ID #: DAM001DFM
• Status: Completed
• Phase: Early Phase 1
• First received: April 26, 2016
• Last updated: June 1, 2017
• Start date: November 1, 2016
• Est. completion date: June 1, 2017

Study information

• Verified date: June 2017
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Addiction
• Cocaine-Related Disorders

Intervention

Drug:
• Dexamphetamine
Participants will receive 60 mg Dexamphetamine SR daily for 5 consecutive days

Locations

Country	Name	City	State
Netherlands	AMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Curve (AUC) of dexamphetamine		Determined on the 5 day bloodsamples taken
Primary	Maximum plasma concentration (Cmax) of dexamphetamine		Determined on the 5 day bloodsamples taken
Primary	Half life (T 1/2) of dexamphetamine		Determined on the 5 day bloodsamples taken