Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients… (NCT03708900) | Clinical Trial Compass
RecruitingPhase 2
Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome
United States12 participantsStarted 2021-04-28
Plain-language 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.
Who can participate
Age range2 Years – 17 Years
SexALL
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Inclusion criteria
✓. Male and female children and adolescents from 2 to \< 18 years of age with Cushing's syndrome of endogenous origin: Who have failed surgery (or) who are awaiting surgery (or) for whom surgery is not an immediate option. For patients who are awaiting surgery, the study treatment could be less than 12 weeks.
✓. Patients must weigh \> 10 kg.
✓. The diagnosis of Cushing's syndrome must be confirmed by each of the following:
Exclusion criteria
✕. Patients with macroadenoma complicated by compressive symptoms (requiring urgent surgical intervention) or at high risk for compressive symptoms due to mass effect of tumor (concern of corticotroph tumor progression).
✕. Insufficient washout period from any other medication used to lower cortisol levels (5 half-lives of any drug).
✕. Use of other investigational drugs at the time of enrollment, or within 30 days, or prior to completion of a wash-out duration that is at least 5 half- lives of the drug, at the time of enrollment, whichever is longer. Local regulations may require a longer wash-out period or specify other limitations for participation in an investigational trial, in which case they will be applicable as well.
✕. History of hypersensitivity to drugs of the same or similar chemical classes as osilodrostat.
✕. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
✕. Patients with moderate to severe renal impairment (estimated GFR \< 60 mL/min by the Creatinine-based "Bedside Schwartz" equation).
What they're measuring
1
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