Trial Condition(s):
Sorafenib drug drug interaction study in healthy male subjects
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
Locations | Status | ||
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Locations Investigative Site Berlin, Germany, 13353 | Status Completed | Contact Us: 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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1