drugset
drugset / Trial / NCT03096080

A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

NCT03096080 ↗

Phase 1 Completed 10 enrolled Kadmon Corporation, LLC
Non-randomizedSequentialOpen-labelTreatment

Summary

This study evaluates safety and tolerability of a single ascending dose of a tesevatinib liquid formulation administered to pediatric subjects with ARPKD.

Timeline

Start
2017-08-24
Primary completion
2019-09-30
Completion
2019-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tesevatinib Small molecule 0.25 mg/kg Oral
Subject Tesevatinib Small molecule 0.5 mg/kg Oral
Subject Tesevatinib Small molecule 1 mg/kg Oral

Indications

autosomal recessive polycystic kidney disease