A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat
Status:
Not yet recruiting
Trial end date:
2021-11-06
Target enrollment:
Participant gender:
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.