drugset
drugset / Trial / NCT03708900

Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome

NCT03708900 ↗

Phase 2 Recruiting 12 enrolled RECORDATI GROUP
NaSingle-groupOpen-labelTreatment

Summary

Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.

Timeline

Start
2021-04-28
Primary completion
2027-07-21
Completion
2027-07-21

Drugs

EvaluationDrugModalityDoseRoute
Subject osilodrostat Small molecule 0.1 mg Oral
Subject osilodrostat Small molecule 0.2 mg Oral
Subject osilodrostat Small molecule 0.5 mg Oral
Subject osilodrostat Small molecule 1 mg Oral
Subject osilodrostat Small molecule 5 mg Oral
Subject osilodrostat Small molecule 10 mg Oral

Indications

Cushing syndrome