Sorafenib Drug Drug Interaction Study in Healthy Male Subjects

Bayer

Status and phase

Completed

Phase 1

Conditions

Drug Interactions

Treatments

Drug: Sorafenib (Nexavar, BAY43-9006)

Drug: Levothyroxine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02332031

17436

2014-001907-36 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

25 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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