drugset / Trial / NCT01526746

Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment and Matched Control Subjects With Relatively Normal Renal Function

NCT01526746

Phase 1 Completed 32 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 (including its breakdown products) in the blood of individuals with severe renal impairment compared to individuals who have normal renal function. The safety and tolerability of tasimelteon will also be assessed throughout this study.

Timeline

Start
2012-02
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject tasimelteon Small molecule 20 mg