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

NCT04955340 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-02-18

No results posted yet for this study

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

Interventions

DRUG

[14C]-resminostat

1 single dose of 400 mg \[14C\]-resminostat

Sponsors & Collaborators

  • 4SC AG

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2022-01-19
Completion
2022-01-19

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04955340 on ClinicalTrials.gov