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The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. The results of this study will support treatment and dosing decisions for patients with varying degrees of hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Normal Hepatic Function | Other | Normal hepatic function - Control - control group |
|
| Group 2 - Mild Hepatic Impairment | Experimental | Mild hepatic impairment - Child-Pugh A (Score 5-6) |
|
| Group 3 - Moderate Hepatic Impairment | Experimental | Moderate hepatic impairment - Child-Pugh B (Score 7-9) |
|
| Group 4 - Severe Hepatic Impairment | Experimental | Severe hepatic impairment - Child-Pugh C (score 10-15) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LJN452 | Drug | Dose A single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The maximum (peak) observed drug concentration after single dose administration (mass x volume-1) | Up to 8 days |
| Tmax | Time to reach the maximum (peak) plasma drug concentration after single dose administration (time) | Up to 8 days |
| AUClast | The area under the concentration-time curve from time zero to the time of the last quantifiable concentration sampling time (mass x time x volume-1) | Up to 8 days |
| AUCinf | The area under the concentration-time curve from time zero to infinity (mass x time x volume-1) | Up to 8 days |
| T1/2 | The elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve | Up to 8 days |
| CL/F | The apparent total body clearance of the drug from plasma (volume x time-1) | Up to 8 days |
| Vz/F | The apparent volume of distribution during the terminal phase | Up to 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| fu | Fraction of analyte unbound calculated in-vitro | Day 1 |
| Cmax,u | The maximum (peak) observed plasma drug concentration after single dose administration (Cmax) of unbound drug (mass x time x volume-1), calculated as Cmax*fu |
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All subjects:
Inclusions Criteria:
Exclusion Criteria:
Healthy Volunteers:
Inclusion Criteria:
- In good health as determined by past medical history, physical examination, ECG, laboratory tests, and urinalysis at Screening.
Exclusion Criteria:
Hepatically Impaired Subjects:
Inclusion Criteria:
- Hepatic impairment as defined by the Child-Pugh classification for severity of liver disease
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Orlando | Florida | 32806 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CCLJN452A2109 can be found on the Novartis Clinical Trial Results Website | View source |
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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| Day 1 |
| AUClast,u | The area under the concentration-time curve from time zero to the last quantifiable concentration sampling time of unbound drug (mass x time x volume-1), calculated as AUClast*fu | Day 1 |
| AUCinf,u | The area under the concentration-time curve from time zero to infinity of unbound drug (mass x time x volume-1), calculated as AUCinf*fu | Day 1 |
| CL/F,u | The apparent total body clearance of drug from the plasma of unbound drug (volume x time-1), calculated as CL/F/fu | Day 1 |
| Orlando |
| Florida |
| 32809 |
| United States |
| Novartis Investigative Site | Knoxville | Tennessee | 37920 | United States |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000630573 | tropifexor |
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