Dexamphetamine Sustained Release Pharmacokinetics and Cli... | NCT02768441

Studies
Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

NCT02768441

Sponsor

The Netherlands Cancer Institute

Status

Completed

Last Update Posted

Jun 2, 2017Actual

Enrollment

12Actual

Phase

Early Phase 1

Conditions

Cocaine Addiction

Interventions

Dexamphetamine

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2016Actual

Primary Completion Date

Jun 1, 2017Actual

Completion Date

Jun 1, 2017Actual

First Submitted Date

Apr 26, 2016

First Submission Date that Met QC Criteria

May 10, 2016

First Posted Date

May 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2017

Last Update Posted Date

Jun 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Participants receiving Dexamphetamine 60 mg SR	Drug: Dexamphetamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamphetamine	Drug	Participants will receive 60 mg Dexamphetamine SR daily for 5 consecutive days	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wim van den Brink, PhD	Academic Psychiatric Center AMC-UvA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AMC		Amsterdam			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D019970	Cocaine-Related Disorders

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003913	Dextroamphetamine

Ancestor Terms

ID	Term
D000661	Amphetamine
D000662	Amphetamines
D010627	Phenethylamines
D005021	Ethylamines

Browse Leaves

Not provided

Browse Branches

Not provided