Bioavailability and ADME study of [14C]-derazantinib (QSC201573)
Research type
Research Study
Full title
A Phase 1, two-part, open-label, single-oral-dose study to investigate the absolute bioavailability and absorption, pharmacokinetics, distribution, metabolism, and excretion of [14C]-derazantinib in healthy male subjects
IRAS ID
263875
Contact name
Agnes Kaelin Aebi, PhD
Contact email
Sponsor organisation
Basilea Pharmaceutica International Ltd
Eudract number
2019-001690-81
Duration of Study in the UK
0 years, 3 months, 15 days
Research summary
The Sponsor is developing the test medicine, derazantinib, for the potential treatment of a range of cancers. To better understand how derazantinib behaves in the body, this study is being conducted to identify the amount of test medicine that reaches the bloodstream after it is given by mouth and also to investigate the routes and rates of absorption, movement, breakdown and removal of the test medicine in the body.
The study will consist of 2 parts, each enrolling 6 healthy male subjects. In both parts, volunteers will take the test medicine radiolabelled with carbon-14 (14C). “Radiolabelled” means the test medicine has a radioactive component that helps researchers to track the medicine in the body.
In Part 1 volunteers will take a 300 mg dose of non-radiolabelled test medicine by swallowing 3 x 100 mg capsules. Approximately eight hours later they will receive a 100 µg intravenous dose (directly into the vein) which will be radiolabelled with 14C. The level of radiolabelled and non-radiolabelled test medicine in the blood will then be compared.
In Part 2 volunteers will take a 300 mg dose of the test medicine radiolabelled with 14C by swallowing 3 x 100 mg capsules. The level of test medicine, breakdown products and radioactivity in the blood, urine and faeces will then be measured.
In both parts volunteers will remain resident in the clinical unit until Day 22. During this time, blood, urine and faecal samples will be collected for analysis. Subjects enrolled into Part 1 will be required to attend four return visits. Subjects in Part 2 will be required to attend two return visits, with an additional two return visits if radioactivity recovery criteria have not been met by return visit 2. An end of study (EOS) visit will be conducted on Day 50 for each volunteer.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0225
Date of REC Opinion
7 Aug 2019
REC opinion
Further Information Favourable Opinion