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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tasimelteon Oral Capsule; Drug: Tasimelteon Oral Suspension

• Registration Number: NCT05572281
• Lead Sponsor: Vanda Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-18
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence B	Tasimelteon Oral Capsule	tasimelteon capsule formulation then tasimelteon liquid suspension formulation
Sequence B	Tasimelteon Oral Suspension	tasimelteon capsule formulation then tasimelteon liquid suspension formulation
Sequence A	Tasimelteon Oral Capsule	tasimelteon liquid suspension formulation then tasimelteon capsule formulation
Sequence A	Tasimelteon Oral Suspension	tasimelteon liquid suspension formulation then tasimelteon capsule formulation

Primary Outcome Measures

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

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Springfield, Missouri, United States