Trial Condition(s):

Drug interactions

Sorafenib drug drug interaction study in healthy male subjects

Bayer Identifier:

17436

ClinicalTrials.gov Identifier:

NCT02332031

EudraCT Number:

2014-001907-36

EU CT Number:

Not Available

Study Completed

Trial Purpose

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

Trial Summary

Enrollment Goal
25
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Locations
Locations

Investigative Site

Berlin, Germany, 13353

Trial Design