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NCT02332031 Clinical Trial

Sorafenib Drug Drug Interaction Study in Healthy Male Subjects

Drug Interactions Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02332031
Other study ID # 17436
Secondary ID 2014-001907-36
Status Completed
Phase Phase 1
First received January 5, 2015
Last updated October 9, 2015
Start date February 2015
Est. completion date September 2015

Study information
Verified date October 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date September 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Single dose of 400 mg orally on Period 1 Day 1 and Period 2 Day 11
• Levothyroxine
Single dose of 300 mcq orally from Period 2 Day 1 to Period 2 Day 14

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of sorafenib Period 1 Day 1 and Period 2 Day 11: Predose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 h post-dose No
Secondary AUC from time 0 to the last data point > LLOQ (AUC(0-tlast))of Sorafenib and metabolite M-2 Period 1 Day 1 and Period 2 Day 11: Predose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 h post-dose No
Secondary Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of Sorafenib and metabolite M-2 Period 1 Day 1 and Period 2 Day 11: Predose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 h post-dose No
Secondary Time to reach Cmax (in case of two identical Cmax values, the first tmax will be used) (Tmax Sorafenib) and metabolite M-2 Period 1 Day 1 and Period 2 Day 11: Predose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 h post-dose No
Secondary Half-life associated with the terminal slope (t1/2) of Sorafenib and metabolite M-2 Period 1 Day 1 and Period 2 Day 11: Predose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 h post-dose No
Secondary Apparent volume of distribution at steady state after extravascular administration (Vss/F) of Sorafenib Period 1 Day 1 and Period 2 Day 11: Predose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 h post-dose No
Secondary Total body clearance of Sorafenib calculated after extravascular administration (CL/F) Period 1 Day 1 and Period 2 Day 11: Predose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 h post-dose No
Secondary AUC of metabolite M-2 Period 1 Day 1 and Period 2 Day 11: Predose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 h post-dose No
Secondary Metabolite to parent AUC(0-tlast) ratios Period 1 Day 1 and Period 2 Day 11: Predose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 h post-dose No
Secondary Number of participants with adverse events as a measure of safety and tolerability Up to 15 weeks Yes
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