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NCT02571816
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215
Phase 1 trial testing ASP2215 in Hepatic Impairment in 24 participants. Completed in 5 March 2016.
5 March 2016
Quick facts
| Lead sponsor | Astellas Pharma Global Development, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 23 October 2015 |
| Primary completion | 5 March 2016 |
| Estimated completion | 5 March 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ASP2215 — full drug profile →
Conditions studied
- Hepatic Impairment — all drugs for Hepatic Impairment →
- Healthy — all drugs for Healthy →
Sponsor
Astellas Pharma Global Development, Inc. — full company profile →
Who can join
Adults 18 to 75, any sex, with Hepatic Impairment or Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function. This study will also assess the safety and tolerability of single-dose ASP2215 in subjects with mild and moderate hepatic impairment and matched control subjects.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmacokinetic Profile of Gilteritinib: A Novel FLT-3 Tyrosine Kinase Inhibitor.
James AJ, Smith CC, Litzow M, Perl AE, et al · · 2020 · cited 51× · PMID 32304015 · DOI 10.1007/s40262-020-00888-w
Verify or expand the search:
- PubMed search for NCT02571816
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ASP2215
Trials testing the same drug.
- NCT03315299 — Individual Patient Expanded Access Gilteritinib (ASP2215) · no longer available
Other recruiting trials for Hepatic Impairment
Currently open trials in the same condition.
- NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
- NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
- NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
- NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
- NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting
Other Astellas Pharma Global Development, Inc. trials
Trials by the same sponsor.
- NCT07488676 — A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07475806 — A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep · Phase 2 · recruiting
- NCT07425574 — A Study to Learn How Stargardt-type Eye Conditions Progress in Children and Adults · recruiting
- NCT07409272 — A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherap · Phase 3 · recruiting
- NCT07287995 — A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors · Phase 1, PHASE2 · 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 NCT02571816 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Astellas Pharma Global Development, Inc.
- Last refreshed: 5 November 2024
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/NCT02571816.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing