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NCT02998775
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
EARLY_PHASE1 trial testing Plasma Sampling in Hepatic Impairment; Renal Impairment in 54 participants. Completed in 8 July 2017.
8 July 2017
Quick facts
| Lead sponsor | Eisai Inc. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 54 |
| Start date | 2 December 2016 |
| Primary completion | 8 July 2017 |
| Estimated completion | 8 July 2017 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Plasma Sampling — full drug profile →
Conditions studied
- Hepatic Impairment; Renal Impairment — all drugs for Hepatic Impairment; Renal Impairment →
Sponsor
Eisai Inc. — full company profile →
Who can join
Adults 18 to 79, any sex, with Hepatic Impairment; Renal Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. The primary objective of the study is to obtain plasma from participants for use in in vitro protein binding studies.
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 NCT02998775
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Eisai Inc. trials
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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 NCT02998775 (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 Eisai Inc.
- Last refreshed: 7 September 2018
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/NCT02998775.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing