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To assess the pharmacokinetics of a single oral dose of osilodrostat (LCI699) 30 mg in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic 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 5 day treatment period (a single 30 mg dose of LCI699 ( Day 1) with 5 days of PK sample collection). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| osilodrostat | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of a single dose of 30 mg osilodrostat: AUClast | To assess the influence of hepatic impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function. | Predose (Day 0) , and at timepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose. |
| PK of a single dose of 30 mg osilodrostat: AUCinf | To assess the influence of hepatic impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function. | Predose (Day 0) , and at imepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose. |
| PK of a single dose of 30 mg osilodrostat: Cmax | To assess the influence of hepatic impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function. | Predose (Day 0) , and at timepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose. |
| PK of a single dose of 30 mg osilodrostat: T1/2 | To assess the influence of hepatic impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function. | Predose (Day 0) , and at timepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose. |
| PK of a single dose of 30 mg osilodrostat: CL/F | To assess the influence of hepatic impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function. | Predose (Day 0) , and at timepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| The relationship between PK parameters (Cmax and AUC) and baseline hepatic function parameters namely; total bilirubin, albumin, INR (or prothrombin, if INR unavailable) | To evaluate the relationship between hepatic function parameters and pharmacokinetics. | Predose ( Day 0) and at timepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply -
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami / Clinical Research Services, Inc. Boynton Beach | Miami | Florida | 33136 | United States | ||
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| Label | URL |
|---|---|
| Novartis results database | View source |
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| ID | Term |
|---|---|
| C553306 | Osilodrostat |
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| PK of a single dose of 30 mg osilodrostat: Vz/F | To assess the influence of hepatic impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function. | Predose (Day 0) , and timepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose. |
| Number of participants with adverse events (AEs) | This will be assessed using laboratory abnormalities, ECG and vital sign assessments of a single 30 mg dose of LCI699 | Pre-treatment, during treatment (Day 1) and 30 days post treatment. |
| Orlando Clinical Research Center |
| Orlando |
| Florida |
| 32809 |
| United States |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |