Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04955340
Status:
COMPLETED
Last Update Posted:
2022-02-18
First Post:
2021-06-23
Brief Title:
A Phase 1 Open-label Study of the Absorption Metabolism Excretion of 14C-Resminostat
Sponsor:
4SC AG
Organization:
4SC AG
Study Overview
Official Title:
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
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 8448213 | OTHER | Covance Study Number | None |
| 2021-000555-39 | EUDRACT_NUMBER | None | None |