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Completed

NCT Number: NCT05572281

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanda Investigational Site

Springfield, Missouri, 65802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tasimelteon Oral Capsule

Drug

No additional information

Tasimelteon Oral Suspension

Drug

No additional information

Primary outcomes

  1. Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation

    Time frame: 8 hours

    as measured by plasma concentrations

  2. Assessment of Safety and Tolerability of the liquid suspension and capsule formulation of tasimelteon

    Time frame: 7 days

    as measured by incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 7, 2022
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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