To evaluate the effect of levothyroxine on the absorption, distribution, metabolization and elimination of sorafenib and safety in healthy male subjects
- 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.
- 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
Berlin, Germany, 13353
E-mail: [email protected]
Phone: Not Available
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
Single Group Assignment