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NCT04335266

A Food Effect Study of SHR2554 on Healthy Chinese Male Adult Subjects

Completed Phase 1 Last updated 6 April 2020
What this trial tests

Phase 1 trial testing SHR2554 in Healthy Adult Subjects in 20 participants. Completed in 30 March 2020.

Timeline
6 August 2019
Primary endpoint
9 September 2019
30 March 2020

Quick facts

Lead sponsorJiangsu HengRui Medicine Co., Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposebasic science
Enrollment20
Start date6 August 2019
Primary completion9 September 2019
Estimated completion30 March 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

Adults 40 to 60, male only, with Healthy Adult Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese male adult subjects after oral administration of SHR2554 tablets. The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally in healthy subjects.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Epigenetics-targeted drugs: current paradigms and future challenges.
    Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
  2. Finding an easy way to harmonize: a review of advances in clinical research and combination strategies of EZH2 inhibitors.
    Li C, Wang Y, Gong Y, Zhang T, et al · · 2021 · cited 55× · PMID 33761979 · DOI 10.1186/s13148-021-01045-1
  3. The Endothelium as a Target for Anti-Atherogenic Therapy: A Focus on the Epigenetic Enzymes EZH2 and SIRT1.
    Fledderus J, Vanchin B, Rots MG, Krenning G. · · 2021 · cited 19× · PMID 33562658 · DOI 10.3390/jpm11020103
  4. Study on pharmacokinetic interactions between SHR2554 and itraconazole in healthy subjects: A single-center, open-label phase I trial.
    Deng K, Zou Y, Zou C, Wang H, et al · · 2023 · cited 6× · PMID 35841331 · DOI 10.1002/cam4.5028

Verify or expand the search:

Other trials of SHR2554

Trials testing the same drug.

Other recruiting trials for Healthy Adult Subjects

Currently open trials in the same condition.

Other Jiangsu HengRui Medicine Co., Ltd. trials

Trials by the same sponsor.

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Data sources for this page

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