Drug InteractionsPhase 1NCT02332031
Sorafenib Drug Drug Interaction Study in Healthy Male Subjects
A Phase 1 study testing Sorafenib (Nexavar, BAY43-9006) and Levothyroxine in people with Drug Interactions, run by Bayer at 1 site in Germany.
Trial summary
To evaluate the effect of levothyroxine on the absorption, distribution, metabolization and elimination of sorafenib and safety in healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Interactions
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006) and Levothyroxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
To evaluate the effect of levothyroxine on the absorption, distribution, metabolization and elimination of sorafenib and safety in healthy male subjects
- Conditions
- Drug Interactions
- Being tested
- Sorafenib (Nexavar, BAY43-9006), Levothyroxine
- Keywords
- Sorafenib, levothyroxine, drug interaction, pharmacokinetics, healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (Nexavar, BAY43-9006)Drug
Single dose of 400 mg orally on Period 1 Day 1 and Period 2 Day 11
LevothyroxineDrug
Single dose of 300 mcq orally from Period 2 Day 1 to Period 2 Day 14
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) & Levothyroxine | Experimental | Sorafenib be administrated without and with levothyroxine orally Receives: Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of sorafenib
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Total body clearance of Sorafenib calculated after extravascular administration (CL/F)
Measured: 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
AUC of metabolite M-2
Measured: 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
Metabolite to parent AUC(0-tlast) ratios
Measured: 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
Number of participants with adverse events as a measure of safety and tolerability
Measured: Up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332031
- Sponsor's protocol ID
- 17436
- Other IDs
- 2014-001907-36, 2014
- Status last verified
- Oct 2015
- First submitted
- 5 Jan 2015
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02332031
- Acronym / sponsor ID
- 17436
- Conditions
- Drug Interactions
- Keywords
- Sorafenib, levothyroxine, drug interaction, pharmacokinetics, healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of levothyroxine on the absorption, distribution, metabolization and elimination of sorafenib and safety in healthy male subjects
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) & Levothyroxine | Experimental | Drug: Sorafenib (Nexavar, BAY43-9006), Drug: LevothyroxineSorafenib be administrated without and with levothyroxine orally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006)Single dose of 400 mg orally on Period 1 Day 1 and Period 2 Day 11 | Drug | Sorafenib (Nexavar, BAY43-9006) & Levothyroxine |
| LevothyroxineSingle dose of 300 mcq orally from Period 2 Day 1 to Period 2 Day 14 | Drug | Sorafenib (Nexavar, BAY43-9006) & Levothyroxine |
Primary outcome
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
9 secondary outcomes
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
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
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
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
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
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
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
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
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sorafenib (Nexavar, BAY43-9006) and Levothyroxine in people with Drug Interactions, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.