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RECRUITING
NCT03708900
PHASE2

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

Sponsor: RECORDATI GROUP

View on ClinicalTrials.gov

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.

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 Syndrome

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2021-04-28

Completion Date

2027-07-21

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

LCI699

osilodrostat (LCI699) is in the form of tablets 1 milligram (mg), 5 mg, and 10mg or in form of capsules 0.1 mg, 0.2 mg, 0.5 mg, 1 mg or 5 mg, both the formulations for oral administration

Locations (15)

University of California San Francisco UCSF

San Francisco, California, United States

ABMED Clinical Research Corp

Cape Coral, Florida, United States

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, United States

National Institute of Child Health and Human Development

Bethesda, Maryland, United States

Texas Valley Clinical Research

Weslaco, Texas, United States

UZ Brussel

Jette, Brussels Capital, Belgium

Multiprofile Hospital for Active Treatment Sveta Marina EAD

Varna, Bulgaria

Hospital Necker Enfants Malades

Paris, France

Robert Debre Hospital

Paris, France

CHU Bicetre APHP Paris Saclay

Paris, France

Aziendal Ospedaliero Universitaria Pisana Presidio Ospedale di Cisanello

Pisa, PI, Italy

Ospedale Bambino Gesu

Roma, Italy

University Clinical Center Ljubljana

Ljubljana, Slovenia

Alder Hey Childrens NHS Foundation Trust

Liverpool, United Kingdom

The Royal London Childrens Hospital

London, United Kingdom