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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003528-35 | EudraCT Number |
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To characterize the pharmacokinetics of LCI699 following a single oral dose in adult subjects with various degrees of impaired renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| osilodrostat ( LCI699) | Experimental | Each participant will undergo a 28 day screening /baseline period (day-28 to Day -1), followed by a 4 day treatment period ( a single 30 mg dose of LCI699 (Day 1) with 4 days of PK smple collection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| osilodrostat | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUClast | To assess the influence of renal impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of renal impairment compared to subjects with normal renal function. | Pre-dose (Day 0), and at timepoints 05.1,1.5,2,3,4,6,8,12,24,36,28 and 72 hours post dose |
| Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUCinf | To assess the influence of renal impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of renal impairment compared to subjects with normal renal function. | Pre-dose (Day 0), and at timepoints 05.1,1.5,2,3,4,6,8,12,24,36,28 and 72 hours post dose |
| Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: Cmax | To assess the influence of renal impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of renal impairment compared to subjects with normal renal function. | Pre-dose (Day 0), and at timepoints 05.1,1.5,2,3,4,6,8,12,24,36,28 and 72 hours post dose |
| Pharmacokinetics (PK in urine) of a single dose of 30 mg osilodrostat: CL/F | To assess the influence of renal impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of renal impairment compared to subjects with normal renal function. | Pre-dose (Day 0), and at timepoints 05.1,1.5,2,3,4,6,8,12,24,36,28 and 72 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| The relationship between PK parameters (, T1/2, V2/F and urine AeOt) | Pre-dose (Day 0), and at timepoints 05.1,1.5,2,3,4,6,8,12,24,36,28 and 72 hours post dose | |
| Number of participants with adverse events | Pre-treatment, during treatment (Day1) and 30 days post treatment |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined Inclusion/Exclusion may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Sofia | 1612 | Bulgaria | |||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CLCI699C2104 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C553306 | Osilodrostat |
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| Berlin |
| 14050 |
| Germany |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |