SARO.19.003 part A
10 evidence topics · 2 sources
Objective
Hepatic-impairment pharmacokinetic objective
Location and study date
No evidence found.
Study design
Single-dose parallel-group study
Eligibility criteria
Hepatic-function comparison
Treatment
Single-dose hepatic-impairment cohorts
| Regimen | Dose |
|---|---|
| Oral saroglitazar | “4-mg” |
Study outcomes
Rationale for using pharmacokinetic parameters as the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Published hepatic-impairment cohorts
| Population | Participants |
|---|---|
| Hepatic impairment | “Thirty-two” |
| Normal hepatic function | “23” |
Description of analysis sets
Pharmacokinetic analysis
Results
Participant disposition
No evidence found.
Baseline characteristics
No evidence found.
Efficacy results
Hepatic impairment: single-dose study
| Population or parameter | Quoted finding |
|---|---|
| Mild and moderate hepatic impairment | “did not significantly affect the PK of saroglitazar” |
| Severe hepatic impairment: exposure | “increased 3-fold” |
| Severe hepatic impairment: clearance | “61% lower” |
| Severe hepatic impairment: authors’ qualification | “may require close monitoring or dose adjustments” |
Non-cirrhotic cholestatic liver disease: comparison with controls
Health-related quality of life and patient-reported outcomes
Not applicable.
Safety results
Single-dose tolerability
Study limitations
Summary
Single-dose pharmacokinetics do not establish repeated-dose safety or clinical efficacy. The 32 participants with hepatic impairment and 23 controls describe the published hepatic-impairment cohorts, not every cohort subsequently reported under this protocol. Severe impairment increased exposure, limiting extrapolation from mild or moderate impairment.