drugset / Trial / NCT01477619

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

NCT01477619

Phase 1 Completed 60 enrolled Vanda Pharmaceuticals
Non-randomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2011-11
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject tasimelteon Small molecule 20 mg

Indications

No indication recorded.