NCT05967377

Evaluating the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib (XS005) in Healthy Male Subjects

A Single Part, Open-Label, Randomised, Three-Way Crossover Study Designed to Evaluate the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib From Sorafenib (XS005) Tablets and Capsules Compared With Nexavar® (Reference Product) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Xspray Pharma AB · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single centre, open-label, randomised, single dose, 3-way crossover comparative (PK) and bioavailability study in healthy male subjects comparing a 200 mg Sorafenib (Nexavar®) reference tablet (Regimen A) to XS005 Sorafenib Capsule A, 2 x 50 mg (Regimen B) and XS005 Sorafenib Tablet A,100 mg (Regimen C) formulation. It is planned to enroll 15 subjects who will receive single oral doses of investigational medicinal product (IMP) across 3 treatment periods.

Conditions

• Pharmacokinetics
• Bioavailability

Interventions

Type	Name	Description
DRUG	Sorafenib - Period 1	Sorafenib (Nexavar®) Tablet, 200 mg
DRUG	XS005 Sorafenib Capsule A - Period 1	XS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)
DRUG	XS005 Sorafenib Tablet A - Period 1	XS005 Sorafenib Tablet A, 100 mg
DRUG	XS005 Sorafenib Capsule A - Period 2	XS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)
DRUG	XS005 Sorafenib Tablet A - Period 2	XS005 Sorafenib Tablet A, 100 mg
DRUG	Sorafenib - Period 2	Sorafenib (Nexavar®) Tablet, 200 mg
DRUG	XS005 Sorafenib Tablet A - Period 3	XS005 Sorafenib Tablet A, 100 mg
DRUG	Sorafenib - Period 3	Sorafenib (Nexavar®) Tablet, 200 mg
DRUG	XS005 Sorafenib Capsule A - Period 3	XS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)

Timeline

• Start date: 2018-11-16
• Primary completion: 2019-02-12
• Completion: 2019-02-12
• First posted: 2023-08-01
• Last updated: 2023-08-01

Locations

1 site across 1 country: United Kingdom