Study to determine the Metabolism and Excretion of 14C-E7090 in Males
Research type
Research Study
Full title
An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]-E7090 in Healthy Male Subjects
IRAS ID
279465
Contact name
Jim Bush
Contact email
Sponsor organisation
Eisai Ltd.
Eudract number
2019-004957-10
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
REC Reference Number, 20/NE/0063
Duration of Study in the UK
0 years, 2 months, 27 days
Research summary
E7090 is a novel and potent tyrosine kinase inhibitor that selectively inhibits multiple fibroblast growth factor (FGF) receptors, FGFR1-3. FGFR genetic alterations (e.g. activating mutation, chromosomal translocations, gene amplifications and splicing alternations) are known to be present in various cancer types including lung cancer, breast cancer, endometrial cancer, gastric cancer, bladder cancer and bile duct carcinoma, and play important roles in proliferation, survival and migration of cancer cells.
This study is designed to investigate the pharmacokinetics, metabolism and elimination of 35 mg / 3.7 MBq [14C]-E7090 after a single oral dose in healthy adult male subjects. The essential elimination processes and the rate, routes, and extent of excretion of E7090 and metabolites will also be investigated.
The study will have 2 phases: Pre-treatment and Treatment. The Pre-treatment Phase will last up to 28 days and will consist of a Screening Period and a Baseline Period, during which each subject’s study eligibility will be determined and baseline assessments will be conducted.
After Screening, subjects will be admitted to the clinic on Day -1 and a baseline (pre-dose) fecal and urine sample will be obtained. On Day 1, subjects will begin the Treatment Phase. All subjects will be dosed on Day 1 with 3.7MB of [14C]-E7090 as a single oral 35 mg dose of E7090 (final dose to depend on the specific activity of [14C]-E7090 in the blended material) in the morning after an overnight fast, and will continue to fast post-dose for the next 4 hours.
Up to 8 healthy male subjects are to be enrolled, with the aim of having 6 subjects complete the study.
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0063
Date of REC Opinion
11 Jun 2020
REC opinion
Favourable Opinion