NCT02332031

Sorafenib Drug Drug Interaction Study in Healthy Male Subjects

An Open-label Study in Healthy Male Subjects to Assess the Effect of Hyperthyroidism Mimicked by Oral Dosing of Levothyroxine on the Pharmacokinetics of Sorafenib

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effect of levothyroxine on the absorption, distribution, metabolization and elimination of sorafenib and safety in healthy male subjects

Conditions

• Drug Interactions

Interventions

Type	Name	Description
DRUG	Sorafenib (Nexavar, BAY43-9006)	Single dose of 400 mg orally on Period 1 Day 1 and Period 2 Day 11
DRUG	Levothyroxine	Single dose of 300 mcq orally from Period 2 Day 1 to Period 2 Day 14

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-06-01
• Completion: 2015-09-01
• First posted: 2015-01-06
• Last updated: 2015-10-12

Locations

1 site across 1 country: Germany