drugset / Trial / NCT01559363
A Safety, Pharmacokinetic & Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease
Non-randomizedSequentialOpen-labelTreatment
Summary
The primary objective of this study Phase 1b was to determine the safety, plasma pharmacokinetics, and maximum tolerated dose (MTD) of tesevatinib when administered to participants with autosomal dominant polycystic kidney disease (ADPKD). The primary objective of this study Phase 2a was to evaluate the annualized change in glomerular filtration rate (GFR) in participants with ADPKD when treated with tesevatinib.
Timeline
- Start
- 2012-10-11
- Primary completion
- 2019-02-08
- Completion
- 2019-02-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tesevatinib | Small molecule | 50 mg | Oral |
| Subject | Tesevatinib | Small molecule | 100 mg | Oral |
| Subject | Tesevatinib | Small molecule | 150 mg | Oral |