A Phase 1 AME Study in Oral 14C-Resminostat
Research type
Research Study
Full title
A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat Following a Single Oral Dose in Healthy Male Subjects
IRAS ID
295709
Contact name
Jim Bush
Contact email
Sponsor organisation
4SC AG
Eudract number
2021-000555-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 10 days
Research summary
Resminostat is a potent, orally available inhibitor of Class I, IIb and IV histone deacetylases (HDACs), including a pronounced activity against HDAC6. Resminostat targets epigenetic changes observed in tumour cells and has the potential to provide significant benefit to patients with advanced malignancies by inhibiting tumour progression and metastasis or even inducing tumour regression.
This will be a Phase 1, open-label, non-randomized, single dose study of the absorption, metabolism, excretion of [14C] resminostat following a single oral dose in healthy male participants.
The purpose of this study is to determine the absorption, metabolism, and excretion (AME) of [14C] resminostat and to characterize and determine the metabolites present in plasma, urine, and, where possible, faeces in healthy male participants following a single oral administration. Knowledge of the metabolism and excretion of parent drug and its metabolites is useful for evaluating the Metabolites in Safety Testing requirements elucidated in the International Conference on Harmonisation (ICH) M3, and the likelihood of effects of renal or hepatic impairment on the disposition of resminostat, and the likelihood for drug-drug interactions with resminostat. The results from this study may guide future study designs using special populations or evaluating the potential for drug-drug interactions.
Up to 8 participants will be enrolled and studied as a single group in order that at least 6 participants complete the study.
REC name
North East - York Research Ethics Committee
REC reference
21/NE/0052
Date of REC Opinion
30 Apr 2021
REC opinion
Further Information Favourable Opinion