NCT02332031

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

January 5, 2015

Last Update Submit

October 9, 2015

Conditions

Drug Interactions

Keywords

Sorafenib, levothyroxine, drug interaction, pharmacokinetics, healthy volunteer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +4 more secondary outcomes

Study Arms (1)

Sorafenib (Nexavar, BAY43-9006) & Levothyroxine

EXPERIMENTAL

Sorafenib be administrated without and with levothyroxine orally

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

Interventions

Sorafenib (Nexavar, BAY43-9006)DRUG

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

Sorafenib (Nexavar, BAY43-9006) & Levothyroxine
LevothyroxineDRUG

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

Sorafenib (Nexavar, BAY43-9006) & Levothyroxine

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Interventions

SorafenibThyroxine

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 6, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

DE(1)