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

NCT05572281 | Completed Phase 1 FDA Drug

• 1 other identifier: VP-VEC-162-1113
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sequence A

EXPERIMENTAL

tasimelteon liquid suspension formulation then tasimelteon capsule formulation

Drug: Tasimelteon Oral Capsule; Drug: Tasimelteon Oral Suspension

Sequence B

EXPERIMENTAL

tasimelteon capsule formulation then tasimelteon liquid suspension formulation

Drug: Tasimelteon Oral Capsule; Drug: Tasimelteon Oral Suspension

Interventions

Tasimelteon Oral Capsule DRUG

No additional information

Sequence A; Sequence B

Tasimelteon Oral Suspension DRUG

No additional information

Sequence A; Sequence B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (1)

Vanda Investigational Site

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Interventions

tasimelteon

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: October 7, 2022
• Study Start: May 18, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)