Test-retest of the newly developed P-gp PET tracer [11C]phenytoin in healthy volunteers

Test-retest of the newly developed P-gp PET tracer [11C]phenytoin in healthy volunteers - Test-retest of [11C]phenytoin in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37882

Enrollment

Registered

2012-06-04

Start date

2013-09-21

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

geen (nu nog in gezonde mensen) not applicable

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age between 18-65 years - Good physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests - Weight >50 kg - RDC diagnosis never mentally ill - Written informed consent of each subject

Exclusion criteria

Exclusion criteria: - Any clinical significant abnormality of any clinical laboratory test - Any subject who has received any investigational medication within 30 days prior to the start of this study, or who is scheduled to receive an investigational drug - Major psychiatric or neurological disorder - History of alcohol and/or drug abuse (DSM-IV criteria) - History of coagulation problems - Any sign of cardiovascular disease - Current use of any medication, other than contraceptive medication - Breast feeding - Pregnancy - Unable to understand or read the Dutch language

Design outcomes

Primary

Measure	Time frame
(1) To assess [11C]phenytoin plasma and brain kinetics in healthy volunteer(s), including assessment of the presence of radioactive metabolites in plasma. (2) To determine intra-subject variation of [11C]phenytoin kinetics in humans.	—

Secondary

Measure	Time frame
To develop a tracer kinetic model for [11C]phenytoin in humans.	—

Countries

Netherlands

Outcome results