Non-24-Hour-Sleep-Wake Disorder Clinical Trial
Official title:
A Single Dose, Open-Label, Randomized Two-Period Crossover Study in Healthy Young Subjects to Assess the Absolute Bioavailability of Tasimelteon (HETLIOZ™)
Hetlioz™ (tasimelteon) is used in the treatment of Non-24-Hour-Sleep-Wake Disorder (Non-24).
Non-24 is very common in people who are totally blind because light can not reset their body
clock. This causes the internal sleep-wake cycle to be out of sync with the 24-hour
day-night. Non-24 is a serious, chronic circadian rhythm disorder in the blind that causes
nighttime sleep problems and a wide range of daytime difficulties, including an overwhelming
urge to nap.
Tasimelteon will be given in two ways; orally (by mouth) as a 20 mg capsule and
intravenously (I.V.) by infusion through a catheter (not an injection) into a vein. The oral
administration is approved by the FDA. The I.V. administration is considered investigational
as it has not been approved by the FDA. This will be the first time tasimelteon will be
given to humans by intravenous (I.V.) injection.
The purposes of this research study are to:
- assess how quickly a single 20 mg oral dose of tasimelteon is absorbed into the body;
- evaluate the single-dose pharmacokinetics of tasimelteon after a single 20 mg oral dose
and after a single 2 mg I.V. dose;
- evaluate the single-dose pharmacokinetics of tasimelteon metabolites after a single 20
mg oral dose and after a single 2 mg I.V. dose;
- evaluate the safety and tolerability of a single 20 mg oral dose of tasimelteon; and
- evaluate the safety and tolerability of a single 2 mg I.V. dose of tasimelteon.
Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and
eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood
samples will be taken throughout the study for PK analysis.
n/a
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science