NCT01526746

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

An Open-Label, Single-Dose, Parallel-Group Study to Compare the Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment With That in Matched Control Subjects With Relatively Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Tasimelteon	20mg capsule, once
DRUG	Tasimelteon	20mg, once

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-02-06
• Last updated: 2014-02-17

Locations

3 sites across 1 country: United States