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

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

Inclusion Criteria:

• Healthy male subjects between the ages of 18 (inclusive) and 45 years (inclusive) at the first screening visit.
• Body mass index (BMI) between 18.5 (inclusive) to 30.0 kg / m² (inclusive) with body weight ≥ 65kg.
• Normal thyroid function indicated by thyroid examination to include total and free T3 (Triiodothyronine) , T4 (total and free Thyroxine, levothyroxine), TSH (Thyroid stimulating hormone), anti-TSH-receptor (anti-TSHR) antibody, anti-thyroperoxidase (anti-TPO) antibody, anti-thyroglobulin antibody (anti-ATA) as well as thyroid ultrasound.

Exclusion Criteria:

• History of clinically significant metabolic, renal, hepatic, or central nervous system disorder such as seizure, psychosis and sleep disorders.
• History of cardiovascular diseases including arrhythmia, hypertension, ischemia, etc.
• Known or suspected cardiovascular disease including potential risk of atrioventricular (AV) block, arrhythmia, etc. with or without a formal cardiologist consultation.
• Subjects who had received iodine containing contrast medium within 2 months before first study drug administration.
• Use of systemic or topical medicines or substances which might affect the study drug(s) must be avoided