Phase 1 PK and Bioavailability Study in healthy subjects (QCL118151)
Research type
Research Study
Full title
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
IRAS ID
252619
Contact name
Olga Björklund
Contact email
Sponsor organisation
Xspray Pharma AB
Eudract number
2018-003475-35
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
The Sponsor is developing the test medicine, Sorafenib (XS005), for the potential treatment of a type of liver cancer called unresectable hepatocellular carcinoma (HCC). HCC develops from liver cells and is more common in people who have a damaged liver from cirrhosis (scarring of the liver) which can be caused from previous damage, for example from infections from hepatitis B or C or long term alcohol drinking. \n\nThe study will assess the levels of the test medicine present in the body, as well as looking at the safety and tolerability of the test medicine.\n\nThe study is a single part study involving up to 15 healthy male volunteers. This study involves 3 periods, therefore the volunteers will attend the clinical unit on 3 occasions. The volunteers will be randomly assigned to receive one dose of the test medicine or the reference medicine at each period. For each study period, the volunteers will receive one dose of the test medicine or reference medicine on Day 1 and will be discharged from the clinical unit on Day 2. The volunteers will attend a return visit on Days 3 and 4 and will have a follow up phone call 7 to 10 days following their final dose to check on their continued well being.
REC name
Wales REC 2
REC reference
18/WA/0341
Date of REC Opinion
19 Oct 2018
REC opinion
Further Information Favourable Opinion