Clinical Trials Logo
  1. Home
  2. Mycosis Fungoides
  3. NCT04955340

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

Mycosis Fungoides Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04955340
Study type Interventional
Source 4SC AG
Contact
Status Completed
Phase Phase 1
Start date October 12, 2021
Completion date January 19, 2022
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02881749 - Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Completed NCT00051012 - Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients Phase 4
Terminated NCT03789864 - Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides N/A
Completed NCT01590732 - Romidepsin, Ifosfamide, Carboplatin, and Etoposide in Treating Participants With Relapsed or Refractory Peripheral T-Cell Lymphoma Phase 1
Recruiting NCT02848274 - ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome
Recruiting NCT00177268 - Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Recruiting NCT05357794 - Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides Phase 2
Recruiting NCT04960618 - Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary Syndrome Phase 2
Completed NCT02883517 - Cell-free Circulating DNA in Primary Cutaneous Lymphomas
Active, not recruiting NCT02953301 - Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS) Phase 2
Completed NCT00254332 - Effect of Denileukin Diftitox on Immune System in CTCL Patients N/A
Completed NCT02296164 - Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
Recruiting NCT05680558 - Photopheresis in Early-stage Mycosis Fungoides Phase 2
Completed NCT00038376 - Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies Phase 2
Completed NCT00168064 - Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides Phase 2
Recruiting NCT05879458 - Ritlecitinib in CTCL Phase 2
Recruiting NCT05414500 - Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides Phase 1
Recruiting NCT05904522 - Histopathological Changes in Mycosis Fungoides N/A
Recruiting NCT04256018 - Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome Phase 2