Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Disease
Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's disease.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Open-label, Non-comparative Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Osilodrostat in Children and Adolescent Patients With Cushing's Disease
Estimated Study Start Date: January 31, 2019
Estimated Primary Completion Date: March 22, 2021
Estimated Study Completion Date: January 7, 2022
Arms:
- Experimental: LCI699 (osilodrostat)
Category | Value |
---|---|
Date last updated at source | 2018-12-14 |
Study type(s) | Interventional |
Expected enrolment | 20 |
Study start date | 2019-01-31 |
Estimated primary completion date | 2021-03-22 |