Differences Between Chidamide Taken Daily and Twice a Week in Therapeutic Effect，Pharmacokinetics, Pharmacodynamics and EB Virus Activation

EBV Clinical Trial

Official title: Research About the Differences Between Chidamide Taken Daily and Twice a Week in Pharmacokinetics

Status Not yet recruiting

Clinical Trial Summary

1. To compare the therapeutic effects, safety and the corresponding pharmacokinetics and pharmacodynamics between two different method of drug administration: 10mg, daily and 30mg/d, twice every week, and find out the more effect way of Chidamide administration.

2. To examine whether Chidamide could activate EB virus, and whether the above two different ways of administration are different in EB virus activation.

Clinical Trial Description

Currently, Chidamide is taken twice a week, this comes from cell experiment and phase I clinical trial, which showed that the de-acetylation effect of Chidamide could last for 72 hours after administration. However, daily administration of Chidamide may create a more steady Chidamide concentration, thus improve the de-acetylation effect of Chidamide, so it's necessary to compare the two different ways of administration.

Current study showed that Romidepsin, a HDACI, could activate EBV during the treatment of NKTCL, whether Chidamide, as a novel HDACI, could activate EBV is still not clear, so this problem is worth to be accessed. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• EBV
• Lymphoma, Extranodal NK-T-Cell

• NCT number: NCT02878278
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Huiqiang Huang, Professor
• Email: huanghq@sysucc.org.cn
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2016
• Completion date: September 2019