Biological AvailabilityPhase 1NCT02538393
Relative Bioavailability of Sorafenib Tablet for Oral Suspension
A Phase 1 study testing Sorafenib (BAY43-9006) Film-coated tablet and Sorafenib (BAY43-9006) Oral suspension in people with Biological Availability, run by Bayer at 1 site in Germany.
Trial summary
The primary objective of the study is to Investigate the relative bioavailability of sorafenib as 400 mg (4 x 100 mg) tablet for oral suspension formulation in comparison to 400 mg (2 x 200 mg) marketed tablet formulation. 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
- Biological Availability
- What is being tested?
- Sorafenib (BAY43-9006) Film-coated tablet and Sorafenib (BAY43-9006) Oral suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 20 Nov 2015to 15 Jun 2016
- 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 18.0 (inclusive) and 32.0 kg / m² (inclusive).
- Non-smoker or former smoker who has stopped smoking at least 3 months before the first study drug administration
- Ability to understand and follow study-related instructions
- Any subject who is a sexually active man and has not been surgically sterilized must consent to use a condom during intercourse and ensure that his female partner practices adequate contraception, or he must be willing to refrain from sexual intercourse from the beginning of the trial until 30 days after last study drug administration.
Who cannot join
- Medical and surgical history:
- Failure of a major organ system or a medical disorder that would impair the subject's ability to complete the study or that would alter the absorption and pharmacokinetics of the study drug
- Active infections or other medical, psychological or social problems of sufficient severity to limit full compliance with the trial
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- History of clinically significant metabolic, renal, hepatic, or cardiovascular disease or central nervous system disorder
- Clinically significant illness within 30 days before first study drug administration.
Show all 14Show fewer
- Febrile illness within 1 week before the first study drug administration
- Known hypersensitivity to study drug
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Electrocardiogram (ECG), blood pressure, heart rate:
- Clinically relevant findings in the ECG (e.g. a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTc-interval over 450 msec)
- Laboratory examination:
- Clinically relevant deviations of the screened laboratory parameters from reference ranges (especially for gamma-GT, ALT, AST, or bilirubin)
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of Sorafenib Tablet for Oral Suspension Compared to Marketed Tablet and to Investigate the Pharmacokinetics of Sorafenib Tablet for Oral Suspension Including Food Effect and Dose Proportionality
The primary objective of the study is to
- Investigate the relative bioavailability of sorafenib as 400 mg (4 x 100 mg) tablet for oral suspension formulation in comparison to 400 mg (2 x 200 mg) marketed tablet formulation.
Read more
The secondary objectives of this study are to
- Evaluate the dose proportionality in sorafenib pharmacokinetics for sorafenib tablet for oral suspension formulation after administration of 200 mg (2 x 100 mg) and 400 mg (4 x 100 mg) dose of sorafenib in fasted state
- Evaluate the effect of food on the pharmacokinetics of the tablet for oral suspension formulation after administration of a single dose of 400 mg sorafenib (4 x 100mg)
- Evaluate the taste and palatability of sorafenib (both formulations)
- Assess the safety and tolerability of sorafenib tablet for oral suspension in healthy male subjects
- Conditions
- Biological Availability
- Being tested
- Sorafenib (BAY43-9006) Film-coated tablet, Sorafenib (BAY43-9006) Oral suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (BAY43-9006) Film-coated tabletDrug
Subjects received a single oral dose of 400 mg sorafenib marketed tablets (2 * 200 mg) in fasting state in Treatment A
Sorafenib (BAY43-9006) Oral suspensionDrug
Treatment C: Subjects received a single oral dose of 200 mg sorafenib tablets for oral suspension (2 * 100 mg) in fasting state in the second intervention period; Treatment B: Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) in fasting state in the third intervention period; Treatment D: Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) after a high-fat, high-calorie breakfast (fed state) in the fourth intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A-C-B-D | Experimental | Subjects received a single oral dose of 400 mg sorafenib marketed tablets (2 * 200 mg) in fasting state (Treatment A) in the first intervention period; followed by a single oral dose of 200 mg sorafenib tablets for oral suspension (2 * 100 mg) in fasting state (Treatment C) in the second intervention period; followed by a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) in fasting state (Treatment B) in the third intervention period; and then a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) after a high-fat, high-calorie breakfast (fed state) (Treatment D) in the fourth intervention period. A washout period of at least 10 days was maintained between sorafenib administrations. Receives: Drug: Sorafenib (BAY43-9006) Film-coated tablet; Drug: Sorafenib (BAY43-9006) Oral suspension |
| Treatment B-A-D-C | Experimental | Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) in fasting state (Treatment B) in the first intervention period; followed by a single oral dose of 400 mg sorafenib marketed tablets (2 * 200 mg) in fasting state (Treatment A) in the second intervention period; followed by a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) after a high-fat, high-calorie breakfast (fed state) (Treatment D) in the third intervention period; and then a single oral dose of 200 mg sorafenib tablets for oral suspension (2 * 100 mg) in fasting state (Treatment C) in the fourth intervention period. A washout period of at least 10 days was maintained between sorafenib administrations. Receives: Drug: Sorafenib (BAY43-9006) Film-coated tablet; Drug: Sorafenib (BAY43-9006) Oral suspension |
| Treatment C-D-A-B | Experimental | Subjects received a single oral dose of 200 mg sorafenib tablets for oral suspension (2 * 100 mg) in fasting state (Treatment C) in the first intervention period; followed by a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) after a high-fat, high-calorie breakfast (fed state) (Treatment D) in the second intervention period; followed by a single oral dose of 400 mg sorafenib marketed tablets (2 * 200 mg) in fasting state (Treatment A) in the third intervention period; and then a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) in fasting state (Treatment B) in the fourth intervention period. A washout period of at least 10 days was maintained between sorafenib administrations. Receives: Drug: Sorafenib (BAY43-9006) Film-coated tablet; Drug: Sorafenib (BAY43-9006) Oral suspension |
| Treatment D-B-C-A | Experimental | Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) after a high-fat, high-calorie breakfast (fed state) (Treatment D) in the first intervention period; followed by a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) in fasting state (Treatment B) in the second intervention period; followed by a single oral dose of 200 mg sorafenib tablets for oral suspension (2 * 100 mg) in fasting state (Treatment C) in the third intervention period; and then a single oral dose of 400 mg sorafenib marketed tablets (2 * 200 mg) in fasting state (Treatment A) in the fourth intervention period. A washout period of at least 10 days was maintained between sorafenib administrations. Receives: Drug: Sorafenib (BAY43-9006) Film-coated tablet; Drug: Sorafenib (BAY43-9006) Oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Versus Time Curve From Zero to Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Sorafenib in Plasma (AUC[0-tlast]) After Single Oral Dose
Area under the concentration versus time curve from zero to the last data point greater than LLOQ after single dose of sorafenib were measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Measured: Pre-dose (0 hour) to 120 hours post-dose
Maximum Observed Drug Concentration After Single Dose Administration (Cmax) of Sorafenib in Plasma
Maximum observed drug concentration after single dose administration of sorafenib in plasma was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Measured: Pre-dose (0 hour) to 120 hours post-dose
Secondary outcomes (9)
Maximum Observed Drug Concentration After Single Dose Administration Divided by Dose (Cmax/D) of Sorafenib in Plasma
Maximum observed drug concentration after single dose administration divided by dose of sorafenib in plasma was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Measured: Pre-dose (0 hour) to 120 hours post-dose
Area Under the Concentration Versus Time Curve From Zero to Infinity After Single Dose (AUC) of Sorafenib in Plasma
Area under the concentration versus time curve from zero to infinity after single dose of sorafenib in plasma was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Measured: Pre-dose (0 hour) to 120 hours post-dose
Area Under the Concentration Versus Time Curve From Zero to Infinity After Single Dose Divided by Dose (AUC/D) of Sorafenib in Plasma
Area under the concentration versus time curve from zero to infinity after single dose divided by dose of sorafenib in plasma. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Measured: Pre-dose (0 hour) to 120 hours post-dose
Area Under the Concentration Versus Time Curve From Zero to Last Data Point Divided by Dose (AUC[0-tlast]/D) of Sorafenib in Plasma
Area under the concentration versus time curve from zero to last data point divided by dose of sorafenib in plasma was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Measured: Pre-dose (0 hour) to 120 hours post-dose
Total Body Clearance of Sorafenib Calculated After Extravascular Administration (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Measured: Pre-dose (0 hour) to 120 hours post-dose
Time to Reach Maximum Concentration (tmax) of Sorafenib in Plasma
Time to reach maximum concentration of sorafenib in plasma.
Measured: Pre-dose (0 hour) to 120 hours post-dose
Half-life Associated With the Terminal Slope (t1/2) of Sorafenib in Plasma
Half-life associated with the terminal slope of sorafenib in plasma. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Measured: Pre-dose (0 hour) to 120 hours post-dose
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs that started or worsened after first administration of study medication up to 30 days after end of treatment with study medication were considered to be treatment-emergent (TE). A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly and another medical important serious event as judged by investigator. SAEs that started or worsened after study drug treatment were recorded as TESAEs.
Measured: From start of study treatment up to 30 days after the last sorafenib dose administration
Number of Subjects With Various Acceptance Regarding the Taste and Palatability of the Tablet Formulations
For each administration of sorafenib, subjects completed a questionnaire regarding the taste and palatability of the tablets for oral suspension or marketed tablets within 5 to 10 min after administration. Results from the questionnaire regarding the taste of tablet, aftertaste and overall impression of the two different tablet formulations were analysed. CD= Completely disagree; SD= Somewhat disagree; Ne= Neutral; SA= Somewhat agree; CA= Completely agree; Un= Unknown.
Measured: Within 5 to 10 min of each administration of sorafenib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start20 Nov 2015
- Primary completion15 Mar 2016
- Study completion15 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AvailabilityStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT02538393
- Sponsor's protocol ID
- 18175
- Other IDs
- 2015-002083-16, 2015
- Status last verified
- May 2017
- First submitted
- 31 Aug 2015
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of Sorafenib Tablet for Oral Suspension Compared to Marketed Tablet and to Investigate the Pharmacokinetics of Sorafenib Tablet for Oral Suspension Including Food Effect and Dose Proportionality
- ClinicalTrials.gov ID
- NCT02538393
- Acronym / sponsor ID
- 18175
- Conditions
- Biological Availability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 15 Mar 2016 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 2 Sep 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.
The primary objective of the study is to
- Investigate the relative bioavailability of sorafenib as 400 mg (4 x 100 mg) tablet for oral suspension formulation in comparison to 400 mg (2 x 200 mg) marketed tablet formulation.
The secondary objectives of this study are to
- Evaluate the dose proportionality in sorafenib pharmacokinetics for sorafenib tablet for oral suspension formulation after administration of 200 mg (2 x 100 mg) and 400 mg (4 x 100 mg) dose of sorafenib in fasted state
- Evaluate the effect of food on the pharmacokinetics of the tablet for oral suspension formulation after administration of a single dose of 400 mg sorafenib (4 x 100mg)
- Evaluate the taste and palatability of sorafenib (both formulations)
- Assess the safety and tolerability of sorafenib tablet for oral suspension in healthy male subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A-C-B-D | Experimental | Drug: Sorafenib (BAY43-9006) Film-coated tablet, Drug: Sorafenib (BAY43-9006) Oral suspensionSubjects received a single oral dose of 400 mg sorafenib marketed tablets (2 * 200 mg) in fasting state (Treatment A) in the first intervention period; followed by a single oral dose of 200 mg sorafenib tablets for oral suspension (2 * 100 mg) in fasting state (Treatment C) in the second intervention period; followed by a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) in fasting state (Treatment B) in the third intervention period; and then a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) after a high-fat, high-calorie breakfast (fed state) (Treatment D) in the fourth intervention period. A washout period of at least 10 days was maintained between sorafenib administrations. |
| Treatment B-A-D-C | Experimental | Drug: Sorafenib (BAY43-9006) Film-coated tablet, Drug: Sorafenib (BAY43-9006) Oral suspensionSubjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) in fasting state (Treatment B) in the first intervention period; followed by a single oral dose of 400 mg sorafenib marketed tablets (2 * 200 mg) in fasting state (Treatment A) in the second intervention period; followed by a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) after a high-fat, high-calorie breakfast (fed state) (Treatment D) in the third intervention period; and then a single oral dose of 200 mg sorafenib tablets for oral suspension (2 * 100 mg) in fasting state (Treatment C) in the fourth intervention period. A washout period of at least 10 days was maintained between sorafenib administrations. |
| Treatment C-D-A-B | Experimental | Drug: Sorafenib (BAY43-9006) Film-coated tablet, Drug: Sorafenib (BAY43-9006) Oral suspensionSubjects received a single oral dose of 200 mg sorafenib tablets for oral suspension (2 * 100 mg) in fasting state (Treatment C) in the first intervention period; followed by a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) after a high-fat, high-calorie breakfast (fed state) (Treatment D) in the second intervention period; followed by a single oral dose of 400 mg sorafenib marketed tablets (2 * 200 mg) in fasting state (Treatment A) in the third intervention period; and then a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) in fasting state (Treatment B) in the fourth intervention period. A washout period of at least 10 days was maintained between sorafenib administrations. |
| Treatment D-B-C-A | Experimental | Drug: Sorafenib (BAY43-9006) Film-coated tablet, Drug: Sorafenib (BAY43-9006) Oral suspensionSubjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) after a high-fat, high-calorie breakfast (fed state) (Treatment D) in the first intervention period; followed by a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) in fasting state (Treatment B) in the second intervention period; followed by a single oral dose of 200 mg sorafenib tablets for oral suspension (2 * 100 mg) in fasting state (Treatment C) in the third intervention period; and then a single oral dose of 400 mg sorafenib marketed tablets (2 * 200 mg) in fasting state (Treatment A) in the fourth intervention period. A washout period of at least 10 days was maintained between sorafenib administrations. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects between the ages of 18 (inclusive) and 45 years (inclusive) at the first screening visit.
- Body mass index (BMI) between 18.0 (inclusive) and 32.0 kg / m² (inclusive).
- Non-smoker or former smoker who has stopped smoking at least 3 months before the first study drug administration
- Ability to understand and follow study-related instructions
- Any subject who is a sexually active man and has not been surgically sterilized must consent to use a condom during intercourse and ensure that his female partner practices adequate contraception, or he must be willing to refrain from sexual intercourse from the beginning of the trial until 30 days after last study drug administration.
Key exclusion criteria (14 listed)
- Medical and surgical history:
- Electrocardiogram (ECG), blood pressure, heart rate:
- Laboratory examination:
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 (BAY43-9006) Film-coated tabletSubjects received a single oral dose of 400 mg sorafenib marketed tablets (2 * 200 mg) in fasting state in Treatment A | Drug | Treatment A-C-B-D, Treatment B-A-D-C, Treatment C-D-A-B, Treatment D-B-C-A |
| Sorafenib (BAY43-9006) Oral suspensionTreatment C: Subjects received a single oral dose of 200 mg sorafenib tablets for oral suspension (2 * 100 mg) in fasting state in the second intervention period; Treatment B: Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) in fasting state in the third intervention period; Treatment D: Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) after a high-fat, high-calorie breakfast (fed state) in the fourth intervention period. | Drug | Treatment A-C-B-D, Treatment B-A-D-C, Treatment C-D-A-B, Treatment D-B-C-A |
Primary outcome
Area Under the Concentration Versus Time Curve From Zero to Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Sorafenib in Plasma (AUC[0-tlast]) After Single Oral Dose
Time frame: Pre-dose (0 hour) to 120 hours post-dose
Area under the concentration versus time curve from zero to the last data point greater than LLOQ after single dose of sorafenib were measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Maximum Observed Drug Concentration After Single Dose Administration (Cmax) of Sorafenib in Plasma
Time frame: Pre-dose (0 hour) to 120 hours post-dose
Maximum observed drug concentration after single dose administration of sorafenib in plasma was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
9 secondary outcomes
Maximum Observed Drug Concentration After Single Dose Administration Divided by Dose (Cmax/D) of Sorafenib in Plasma
Time frame: Pre-dose (0 hour) to 120 hours post-dose
Area Under the Concentration Versus Time Curve From Zero to Infinity After Single Dose (AUC) of Sorafenib in Plasma
Time frame: Pre-dose (0 hour) to 120 hours post-dose
Area Under the Concentration Versus Time Curve From Zero to Infinity After Single Dose Divided by Dose (AUC/D) of Sorafenib in Plasma
Time frame: Pre-dose (0 hour) to 120 hours post-dose
Area Under the Concentration Versus Time Curve From Zero to Last Data Point Divided by Dose (AUC[0-tlast]/D) of Sorafenib in Plasma
Time frame: Pre-dose (0 hour) to 120 hours post-dose
Total Body Clearance of Sorafenib Calculated After Extravascular Administration (CL/F)
Time frame: Pre-dose (0 hour) to 120 hours post-dose
Time to Reach Maximum Concentration (tmax) of Sorafenib in Plasma
Time frame: Pre-dose (0 hour) to 120 hours post-dose
Half-life Associated With the Terminal Slope (t1/2) of Sorafenib in Plasma
Time frame: Pre-dose (0 hour) to 120 hours post-dose
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From start of study treatment up to 30 days after the last sorafenib dose administration
Number of Subjects With Various Acceptance Regarding the Taste and Palatability of the Tablet Formulations
Time frame: Within 5 to 10 min of each administration of sorafenib
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 1 Jun 2017.
Related trials for Biological Availability
Not yet recruitingPhase 1
Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations After Multiple Doses
Obesity, Overweight
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
RecruitingObservational study
Registry of Ehlers-Danlos Syndrome
Ehlers-Danlos Syndrome
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
Not yet recruitingPhase 1
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
Healthy
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 (BAY43-9006) Film-coated tablet and Sorafenib (BAY43-9006) Oral suspension in people with Biological Availability, 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 5 inclusion and 14 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 1 Jun 2017. 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 Versus Time Curve From Zero to Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Sorafenib in Plasma (AUC[0-tlast]) After Single Oral Dose (time frame: Pre-dose (0 hour) to 120 hours post-dose). The study lists 2 primary outcomes in all. 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 1 Jun 2017.