Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

Early Phase 1CompletedNCT02768441

The Netherlands Cancer Institute12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cocaine Addiction

Interventions

DexamphetamineDRUG

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

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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

Locations (1)

AMC

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Area under the Curve (AUC) of dexamphetamine

Time frame: Determined on the 5 day bloodsamples taken

Maximum plasma concentration (Cmax) of dexamphetamine

Time frame: Determined on the 5 day bloodsamples taken

Half life (T 1/2) of dexamphetamine

Time frame: Determined on the 5 day bloodsamples taken

Data from ClinicalTrials.gov

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