NCT02538393

Relative Bioavailability of Sorafenib Tablet for Oral Suspension

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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. 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

Interventions

Type	Name	Description
DRUG	Sorafenib (BAY43-9006) Film-coated tablet	Subjects received a single oral dose of 400 mg sorafenib marketed tablets (2 \* 200 mg) in fasting state in Treatment A
DRUG	Sorafenib (BAY43-9006) Oral suspension	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.

Timeline

• Start date: 2015-11-20
• Primary completion: 2016-03-15
• Completion: 2016-06-15
• First posted: 2015-09-02
• Last updated: 2017-06-01

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study