Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF.
Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
Ability to swallow and retain oral medication.
Subjects having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease having Child-Pugh Turcotte score 7 to 9. If the hepatic impairment classification for the subject is not the same at screening and Day -1, enrolment of the subject into a hepatic category group will be at the discretion of the investigator.
Any significant or unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the investigator
History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e., basal cell or squamous cell carcinoma).
History of stomach or intestinal surgery or resection within 6 months of screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
The history of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the investigator.
Single group
Saroglitazar Magnesium 1 mg
DrugSaroglitazar Magnesium 1 mg will be assigned to all participants enrolled in this open label study
Pharmacokinetics of Saroglitazar: Cmax
Maximum plasma concentration (Cmax)
Pharmacokinetics of Saroglitazar: Tmax
Time to reach maximum plasma concentration (Tmax)
Pharmacokinetics of Saroglitazar: AUCt
The area under plasma concentration vs. time curve till the last time point
Pharmacokinetics of Saroglitazar: AUCi
The area under plasma concentration vs. time curve extrapolated to the infinity
Number of participants with adverse events [Safety and Tolerability]
Number of participants with adverse events
Pharmacokinetics of Saroglitazar sulfoxide: Tmax
Time to reach maximum plasma concentration
Pharmacokinetics of Saroglitazar sulfoxide: Cmax
Maximum plasma concentration
Pharmacokinetics of Saroglitazar sulfoxide: CL/F
The apparent clearance
Click on the lead sponsor to view all of their trials.
