Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers

Study Overview
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Brief Summary
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This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers.

Official Title
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An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of Tasimelteon Capsule Formulation Relative to Tasimelteon Liquid Suspension Formulation in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tasimelteon Oral Capsule
* Drug: Tasimelteon Oral Suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female participants between 18 to 55 years (inclusive). Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit. Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI. Exclusion Criteria: Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations. Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded. Participants with history of smoking or use of tobacco products in the last 3 months. Pregnant or nursing (lactating) women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>tasimelteon liquid suspension formulation then tasimelteon capsule formulation | Drug: Tasimelteon Oral Capsule<br>* No additional information<br>Drug: Tasimelteon Oral Suspension<br>* No additional information<br>|
| Experimental: Sequence B<br>tasimelteon capsule formulation then tasimelteon liquid suspension formulation | Drug: Tasimelteon Oral Capsule<br>* No additional information<br>Drug: Tasimelteon Oral Suspension<br>* No additional information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation | as measured by plasma concentrations | 8 hours | 
| Assessment of Safety and Tolerability of the liquid suspension and capsule formulation of tasimelteon | as measured by incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs | 7 days |