Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

Early Phase 1

Completed

• Conditions: Cocaine Addiction
• Interventions: Drug: Dexamphetamine

• Registration Number: NCT02768441
• Lead Sponsor: The Netherlands Cancer Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Study Start: 2016-11-01
• Status Verified: 2017-06
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Dexamphetamine	Participants receiving Dexamphetamine 60 mg SR

Primary Outcome Measures

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

Trial Locations

Locations (1)

AMC; 🇳🇱 Amsterdam, Netherlands