Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Disease
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ClinicalTrials.gov Identifier: NCT03708900 |
Recruitment Status : Unknown
Verified May 2022 by RECORDATI GROUP.
Recruitment status was: Recruiting
First Posted : October 17, 2018
Last Update Posted : May 6, 2022
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Sponsor:
RECORDATI GROUP
Information provided by (Responsible Party):
RECORDATI GROUP
Tracking Information | |||||
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First Submitted Date ICMJE | October 8, 2018 | ||||
First Posted Date ICMJE | October 17, 2018 | ||||
Last Update Posted Date | May 6, 2022 | ||||
Actual Study Start Date ICMJE | April 28, 2021 | ||||
Estimated Primary Completion Date | February 21, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Disease | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's disease. | ||||
Detailed Description | The period 1 study duration will be 12 weeks. The study will include a screening period of up to 4 weeks prior to Day 0 (baseline) (to allow for an adequate washout period from any medications that may modify cortisol levels). All subjects being treated with osilodrostat at 12 weeks and obtaining benefit from therapy, per investigator judgment, will be offered participation in an optional 9-month extension period, during which assessment of the PD activity and safety/tolerability of osilodrostat will be done. Patients who do not enter the optional extension period will have a safety follow up visit 4 weeks later. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Cushing's Disease | ||||
Intervention ICMJE | Drug: LCI699
osilodrostat (LCI699) is in the form of tablets for oral administration and comes in the following tablet strengths: 1 milligram (mg), 5 mg, and 10mg.
Other Name: osilodrostat
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Study Arms ICMJE | Experimental: LCI699 (osilodrostat)
Subjects with cushing's disease taking LCI699 (osilodrostat)
Intervention: Drug: LCI699
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
12 | ||||
Original Estimated Enrollment ICMJE |
20 | ||||
Estimated Study Completion Date ICMJE | November 29, 2023 | ||||
Estimated Primary Completion Date | February 21, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Years to 17 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Belgium, Bulgaria, Italy, Slovenia, United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03708900 | ||||
Other Study ID Numbers ICMJE | CLCI699C2203 2018-001522-25 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | RECORDATI GROUP | ||||
Original Responsible Party | Novartis Pharmaceuticals | ||||
Current Study Sponsor ICMJE | RECORDATI GROUP | ||||
Original Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | RECORDATI GROUP | ||||
Verification Date | May 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |