check_circleStudy Completed

Drug interactions

Bayer Identifier:
17436
ClinicalTrials.gov Identifier:
NCT02332031
EudraCT Number:
2014-001907-36
EU CT Number:
Not Available
Sorafenib drug drug interaction study in healthy male subjects

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - 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

Trial summary

Enrollment Goal
25
Trial Dates
February 2015 - September 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Berlin, 13353, Germany

Primary Outcome

  • Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of sorafenib
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • AUC from time 0 to the last data point > LLOQ (AUC(0-tlast))of Sorafenib and metabolite M-2
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of Sorafenib and metabolite M-2
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Time to reach Cmax (in case of two identical Cmax values, the first tmax will be used) (Tmax Sorafenib) and metabolite M-2
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Half-life associated with the terminal slope (t1/2) of Sorafenib and metabolite M-2
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Apparent volume of distribution at steady state after extravascular administration (Vss/F) of Sorafenib
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Total body clearance of Sorafenib calculated after extravascular administration (CL/F)
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • AUC of metabolite M-2
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Metabolite to parent AUC(0-tlast) ratios
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 15 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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

Additional Information

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