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NCT05930119
HMPL-453 Food Effect and PPI Study in Healthy Volunteer Study
Phase 1 trial testing HMPL-453 in Intrahepatic Cholangiocarcinoma in 24 participants. Completed in 28 August 2023.
28 August 2023
Quick facts
| Lead sponsor | Hutchmed |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 17 March 2023 |
| Primary completion | 28 August 2023 |
| Estimated completion | 28 August 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- HMPL-453 — full drug profile →
- Rabeprazole — full drug profile →
Conditions studied
- Intrahepatic Cholangiocarcinoma — all drugs for Intrahepatic Cholangiocarcinoma →
Sponsor
Hutchmed — full company profile →
Who can join
Adults 18 to 55, any sex, with Intrahepatic Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Phase 1, Open-label, 4-Period, Randomized 6-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-453 in Healthy Volunteers
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05930119
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HMPL-453
Trials testing the same drug.
- NCT04353375 — HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma · Phase 2, PHASE3 · recruiting
- NCT04290325 — HMPL-453 in Advanced Malignant Mesothelioma · Phase 2 · unknown
- NCT03160833 — A Study of HMPL-453 in Patients With Advanced Solid Malignancies · Phase 1, PHASE2 · unknown
Other recruiting trials for Intrahepatic Cholangiocarcinoma
Currently open trials in the same condition.
- NCT06990659 — Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC) · NA · recruiting
- NCT06910722 — Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy · NA · recruiting
- NCT07169734 — A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06664021 — Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperativ · Phase 2 · recruiting
- NCT06505486 — GEMOX-HAIC Plus GEM-SYS in Combination With Lenvatinib and PD-1 Inhibitor for Large Unresectable ICC · recruiting
Other Hutchmed trials
Trials by the same sponsor.
- NCT07409428 — A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL · Phase 3 · recruiting
- NCT07396584 — HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor · Phase 1, PHASE2 · recruiting
- NCT07228247 — A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07348133 — Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets · Phase 1 · completed
- NCT07331194 — Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans · 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 NCT05930119 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hutchmed
- Last refreshed: 6 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05930119.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing