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NCT04335266
A Food Effect Study of SHR2554 on Healthy Chinese Male Adult Subjects
Phase 1 trial testing SHR2554 in Healthy Adult Subjects in 20 participants. Completed in 30 March 2020.
9 September 2019
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 20 |
| Start date | 6 August 2019 |
| Primary completion | 9 September 2019 |
| Estimated completion | 30 March 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- SHR2554 — full drug profile →
Conditions studied
- Healthy Adult Subjects — all drugs for Healthy Adult Subjects →
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):
-
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 -
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 -
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 -
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:
- PubMed search for NCT04335266
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SHR2554
Trials testing the same drug.
- NCT07125950 — SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer · Phase 2 · not yet recruiting
- NCT07294664 — PD1/TGFβ In Combination With SHR2554 or Apatinib And Chemotherapy For First - Line Treatment Of Gastric Cancer · Phase 2 · recruiting
- NCT05592262 — Pharmacokinetic Test of High-fat Diet After Oral Administration of SHR2554 in Healthy Subjects · Phase 1 · completed
- NCT05559008 — A Umbrella Study in R/R PTCL Guided by Molecular Subtypes · Phase 1, PHASE2 · unknown
- NCT04355858 — Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer · Phase 2 · unknown
Other recruiting trials for Healthy Adult Subjects
Currently open trials in the same condition.
- NCT06635226 — Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects · Phase 1 · recruiting
Other Jiangsu HengRui Medicine Co., Ltd. trials
Trials by the same sponsor.
- NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
- NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
- NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
- NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
- NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04335266 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 6 April 2020
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