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

Part of paid clinical trials in San Francisco, California.

Sponsor
RECORDATI GROUP
Study ID
NCT03708900
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cushing Syndrome

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • LCI699 — DRUG
    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

Study Details

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 Dates

Start date
Apr 28, 2021
Status verified
Mar 2026
Primary completion
Jul 21, 2027
Completion
Jul 21, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LCI699 (osilodrostat)
    Subjects with cushing's syndrome taking LCI699 (osilodrostat)

Primary Outcome Measure

Core Study: Evaluate the pharmacokinetics (PK) of osilodrostat using Pharmacokinetic parameters of osilodrostat up to Week 12 in children and adolescents 2 to less than 18 years of age with Cushing's Syndrome [ Time Frame: up to Week 12 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California San Francisco UCSFSan FranciscoCalifornia94143
Maya Lodish
[email protected]
415-476-3310
ABMED Clinical Research CorpCape CoralFlorida33914
Paige Vanier Kreegel, Dr
[email protected]
Ann & Robert H. Lurie Children's HospitalChicagoIllinois60611
Emily Marshall, Dr
[email protected]
Wendy Brickman (PRINCIPAL_INVESTIGATOR)
National Institute of Child Health and Human DevelopmentBethesdaMaryland20892-
Texas Valley Clinical ResearchWeslacoTexas78596
Eduardo Dusty Luna, Dr
[email protected]

Find similar trials in San Francisco, CA

By research site
University of California San Francisco UCSF· San Francisco, CAABMED Clinical Research Corp· Cape Coral, FLAnn & Robert H. Lurie Children's Hospital· Chicago, ILNational Institute of Child Health and Human Development· Bethesda, MDTexas Valley Clinical Research· Weslaco, TX

Related Studies