NCT01637636

Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.

An Open-label, Single-sequence Study in Two Cohorts of Healthy Subjects to Evaluate the Single-dose Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (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 tasimelteon (including its breakdown product) in the blood when taken alone and in combination with either rifampin or ketoconazole. Cytochrome P450 3A4 is an important enzyme produced by the body to breakdown certain medications. In this study, the effect that this important enzyme has on tasimelteon is being studied by assessing the effect rifampin and ketoconazole have on tasimelteon and how they are broken down by your body. Rifampin is a known inducer of Cytochrome P450 3A4 enzyme meaning that it increases the activity of the enzyme. Ketoconazole is a known inhibitor of Cytochrome P450 3A4 enzyme meaning that it decreases the activity of the enzyme. In addition, the safety and tolerability of tasimelteon will also be assessed throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	tasimelteon	20mg, oral capsule, once, Days 1 and 12
DRUG	tasimelteon	20mg, oral capsule, once, Days 1 and 6
DRUG	Rifampin	600mg, oral capsules (2 x 300mg), once daily (QD), Days 2-11
DRUG	Ketoconazole	400mg, oral tablets (2 x 200mg), once daily (QD), Days 2-6

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-07-11
• Last updated: 2014-02-17

Locations

1 site across 1 country: United States