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NCT05684653
Study to Evaluate Orelabrutinib Tablets in Subjects With Hepatic Impairment and Healthy Subject
Phase 1 trial testing Orelabrutinib Tablets in Hepatic Impairment in 34 participants. Status unknown.
30 December 2023
Quick facts
| Lead sponsor | Beijing InnoCare Pharma Tech Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 34 |
| Start date | 17 March 2023 |
| Primary completion | 30 December 2023 |
| Estimated completion | 30 December 2023 |
| Sites | 4 locations across China |
Drugs / interventions tested
- Orelabrutinib Tablets — full drug profile →
Conditions studied
- Hepatic Impairment — all drugs for Hepatic Impairment →
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd. — full company profile →
Who can join
Adults 18 to 79, any sex, with Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an Open-Label, Parallel, Single-dose, Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Orelabrutinib Tablets in Subjects with Varying Degrees of Hepatic Impairment
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05684653
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatic Impairment
Currently open trials in the same condition.
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Other Beijing InnoCare Pharma Tech Co., Ltd. trials
Trials by the same sponsor.
- NCT06775860 — ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis · Phase 3 · recruiting
- NCT06378138 — ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (AP · Phase 2, PHASE3 · recruiting
- NCT06109818 — Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis · Phase 2 · completed
- NCT06082102 — Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients Wit · Phase 3 · recruiting
- NCT06004856 — Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia · Phase 3 · recruiting
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 NCT05684653 (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 Beijing InnoCare Pharma Tech Co., Ltd.
- Last refreshed: 21 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/NCT05684653.
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