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Sorafenib Drug Drug Interaction Study in Healthy Male Subjects

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug Interactions

Intervention: Sorafenib (Nexavar, BAY43-9006) (Drug); Levothyroxine (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of sorafenib

Secondary outcome:

AUC from time 0 to the last data point > LLOQ (AUC(0-tlast))of Sorafenib and metabolite M-2

Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of Sorafenib and metabolite M-2

Time to reach Cmax (in case of two identical Cmax values, the first tmax will be used) (Tmax Sorafenib) and metabolite M-2

Half-life associated with the terminal slope (t1/2) of Sorafenib and metabolite M-2

Apparent volume of distribution at steady state after extravascular administration (Vss/F) of Sorafenib

Total body clearance of Sorafenib calculated after extravascular administration (CL/F)

AUC of metabolite M-2

Metabolite to parent AUC(0-tlast) ratios

Number of participants with adverse events as a measure of safety and tolerability

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

Berlin 13353, Germany
Additional Information

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Starting date: February 2015
Last updated: July 15, 2015

Page last updated: August 23, 2015

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