NCT04955340

A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat

A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat Following a Single Oral Dose in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: 4SC AG · Industry
• Sex: Male
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cutaneous T Cell Lymphoma
• Mycosis Fungoides
• Sezary Syndrome

Interventions

Type	Name	Description
DRUG	[14C]-resminostat	1 single dose of 400 mg \[14C\]-resminostat

Timeline

• Start date: 2021-10-12
• Primary completion: 2022-01-19
• Completion: 2022-01-19
• First posted: 2021-07-08
• Last updated: 2022-02-18

Locations

1 site across 1 country: United Kingdom