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Last Updated: April 18, 2021

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CLINICAL TRIALS PROFILE FOR HETLIOZ

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All Clinical Trials for HETLIOZ

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02130999 Open Label Study to Assess the Absolute Bioavailability of Tasimelteon (HETLIOZ™) Completed Vanda Pharmaceuticals Phase 4 2014-05-01 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.
NCT02776215 Study of the Pharmacokinetics and Safety of Tasimelteon Children With Non-24-Hour Sleep-Wake Disorder Recruiting Vanda Pharmaceuticals Phase 1 2016-09-01 Open-label, single-dose, non-controlled trial to evaluate the pharmacokinetics and safety of tasimelteon in children from 3 years to less than 18 years of age who are totally blind with no conscious light perception and have Non-24-Hour Sleep-Wake Disorder.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for HETLIOZ

Condition Name

Condition Name for HETLIOZ
Intervention Trials
Non-24-Hour-Sleep-Wake Disorder 1
Non-24 Hour Sleep-Wake Disorder 1
Circadian Rhythm Sleep Disorders 1
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Condition MeSH

Condition MeSH for HETLIOZ
Intervention Trials
Sleep Disorders, Circadian Rhythm 2
Parasomnias 2
Sleep Wake Disorders 2
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Clinical Trial Locations for HETLIOZ

Trials by Country

Trials by Country for HETLIOZ
Location Trials
United States 1
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Trials by US State

Trials by US State for HETLIOZ
Location Trials
Pennsylvania 1
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Clinical Trial Progress for HETLIOZ

Clinical Trial Phase

Clinical Trial Phase for HETLIOZ
Clinical Trial Phase Trials
Phase 4 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for HETLIOZ
Clinical Trial Phase Trials
Completed 1
Recruiting 1
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Clinical Trial Sponsors for HETLIOZ

Sponsor Name

Sponsor Name for HETLIOZ
Sponsor Trials
Vanda Pharmaceuticals 2
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Sponsor Type

Sponsor Type for HETLIOZ
Sponsor Trials
Industry 2
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Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Moodys
Harvard Business School
Baxter
Boehringer Ingelheim

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