drugset / Trial / NCT01540500

Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine

NCT01540500

Phase 1 Completed 24 enrolled Vanda Pharmaceuticals
NaSingle-groupOpen-labelBasic science

Summary

The purpose of this research study is to evaluate whether administration of a CYP1A2 inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The safety and tolerability of tasimelteon will also be assessed throughout the study.

Timeline

Start
2012-02
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluvoxamine Unknown 50 mg
Subject tasimelteon Small molecule 5.66 mg

Indications

No indication recorded.