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Completed

NCT Number: NCT02332031

Sorafenib Drug Drug Interaction Study in Healthy Male Subjects

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

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Key information

Conditions

Drug Interactions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, State of Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Single dose of 400 mg orally on Period 1 Day 1 and Period 2 Day 11

Levothyroxine

Drug

Single dose of 300 mcq orally from Period 2 Day 1 to Period 2 Day 14

Primary outcomes

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

    Time 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

Secondary outcomes

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

    Time 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

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

    Time 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

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

    Time 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

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

    Time 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

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

    Time 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

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

    Time 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

  7. AUC of metabolite M-2

    Time 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

  8. Metabolite to parent AUC(0-tlast) ratios

    Time 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

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

    Time frame: Up to 15 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2015
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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