Non-alcoholic Fatty Liver Disease
Conditions
Keywords
LJN452, tropifexor, PK, safety, healthy subjects, hepatically impaired, Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease, NAFLD
Brief summary
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.
Interventions
DRUGLJN452
Dose A single dose
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
All subjects: Inclusions Criteria: * Subjects must weight at least 50 kg, with a BMI within the range of 18 to 38 kg/m2 * Must be willing to remain in the clinical research unit as required by the protocol
Exclusion criteria
* Use of other study drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations * History of hypersensitivity to the study treatment or to drugs of similar chemical classes * Pregnant or nursing women * Women of child-bearing potential Healthy Volunteers: Inclusion Criteria: \- In good health as determined by past medical history, physical examination, ECG, laboratory tests, and urinalysis at Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vz/F | Up to 8 days | The apparent volume of distribution during the terminal phase |
| Tmax | Up to 8 days | Time to reach the maximum (peak) plasma drug concentration after single dose administration (time) |
| AUClast | Up to 8 days | 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) |
| AUCinf | Up to 8 days | The area under the concentration-time curve from time zero to infinity (mass x time x volume-1) |
| T1/2 | Up to 8 days | The elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve |
| CL/F | Up to 8 days | The apparent total body clearance of the drug from plasma (volume x time-1) |
| Cmax | Up to 8 days | The maximum (peak) observed drug concentration after single dose administration (mass x volume-1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,u | Day 1 | 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 |
| AUClast,u | Day 1 | 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 |
| AUCinf,u | Day 1 | 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 |
| CL/F,u | Day 1 | The apparent total body clearance of drug from the plasma of unbound drug (volume x time-1), calculated as CL/F/fu |
| fu | Day 1 | Fraction of analyte unbound calculated in-vitro |
Countries
United States
Outcome results
None listed