check_circleStudy Completed
Biological Availability
Bayer Identifier:
18175
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Relative bioavailability of sorafenib tablet for oral suspension
Trial purpose
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
• 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
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
30Trial Dates
November 2015 - June 2016Phase
Phase 1Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Berlin, 13353, Germany |
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 DoseArea 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.date_rangeTime Frame:Pre-dose (0 hour) to 120 hours post-doseenhanced_encryptionNoSafety Issue:
- Maximum Observed Drug Concentration After Single Dose Administration (Cmax) of Sorafenib in PlasmaMaximum observed drug concentration after single dose administration of sorafenib in plasma was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Pre-dose (0 hour) to 120 hours post-doseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Maximum Observed Drug Concentration After Single Dose Administration Divided by Dose (Cmax/D) of Sorafenib in PlasmaMaximum 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.date_rangeTime Frame:Pre-dose (0 hour) to 120 hours post-doseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Infinity After Single Dose (AUC) of Sorafenib in PlasmaArea 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.date_rangeTime Frame:Pre-dose (0 hour) to 120 hours post-doseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Infinity After Single Dose Divided by Dose (AUC/D) of Sorafenib in PlasmaArea 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.date_rangeTime Frame:Pre-dose (0 hour) to 120 hours post-doseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Last Data Point Divided by Dose (AUC[0-tlast]/D) of Sorafenib in PlasmaArea 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.date_rangeTime Frame:Pre-dose (0 hour) to 120 hours post-doseenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Pre-dose (0 hour) to 120 hours post-doseenhanced_encryptionNoSafety Issue:
- Time to Reach Maximum Concentration (tmax) of Sorafenib in PlasmaTime to reach maximum concentration of sorafenib in plasma.date_rangeTime Frame:Pre-dose (0 hour) to 120 hours post-doseenhanced_encryptionNoSafety Issue:
- Half-life Associated With the Terminal Slope (t1/2) of Sorafenib in PlasmaHalf-life associated with the terminal slope of sorafenib in plasma. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Pre-dose (0 hour) to 120 hours post-doseenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:From start of study treatment up to 30 days after the last sorafenib dose administrationenhanced_encryptionNoSafety Issue:
- Number of Subjects With Various Acceptance Regarding the Taste and Palatability of the Tablet FormulationsFor 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.date_rangeTime Frame:Within 5 to 10 min of each administration of sorafenibenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
4