NCT01477619

Effects of Smoking, Age and Body Size on Pharmacokinetics, Safety and Tolerability on Tasimelteon in Healthy Subjects

An Open-label, Single Dose, Parallel Group Study to Assess the Effects of Smoking Status, Age and Body Size on the Pharmacokinetics, Safety, and Tolerability of Tasimelteon in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon in the blood in smokers versus non-smokers. Additionally, this study will provide an assessment of the effect, if any, of age and body size on the safety and tolerability profile and the pharmacokinetics of tasimelteon.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Tasimelteon	20mg single dose on Day 1

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-11-22
• Last updated: 2014-02-17

Locations

1 site across 1 country: United States