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NCT04627129

A Itraconazole Effect Study of SHR2554 on Healthy Chinese Adult Subjects

Completed Phase 1 Last updated 13 November 2020
What this trial tests

Phase 1 trial testing SHR2554 and Itraconazole in Healthy Adult Subjects in 18 participants. Completed in 1 October 2020.

Timeline
1 June 2020
Primary endpoint
1 October 2020
1 October 2020

Quick facts

Lead sponsorJiangsu HengRui Medicine Co., Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment18
Start date1 June 2020
Primary completion1 October 2020
Estimated completion1 October 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

Adults 18 to 45, any sex, 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 Itraconazole on pharmacokinetics of healthy Chinese 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

3 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. 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
  3. 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 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.

Verify against primary sources

Data sources for this page

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