NCT01402076

A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects

An Open-Label, Single-Sequence Study to Assess the Effect of Multiple Doses of Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes Using Midazolam and Rosiglitazone as Substrates in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to understand whether there is any difference in the amount of midazolam (including its breakdown product) in the blood when midazolam is given with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the blood when rosiglitazone is given with tasimelteon.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Tasimelteon	20mg daily dosing, Days 4-20
DRUG	Rosiglitazone	4mg, single dose, Days 3 and 20
DRUG	Midazolam	10mg, single dose, Days 1 and 18

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-07-26
• Last updated: 2014-02-17

Locations

1 site across 1 country: United States