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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05572281
• Other study ID #: VP-VEC-162-1113
• Status: Completed
• Phase: Phase 1
• Start date: May 18, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: March 2024
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Tasimelteon Oral Capsule
No additional information
• Tasimelteon Oral Suspension
No additional information

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation	as measured by plasma concentrations	8 hours
Primary	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