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
A phase 1, open-label, single arm study to evaluate pharmacokinetics, safety, and tolerability of Saroglitazar Magnesium dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in this open label study
Zydus Site US001
Indianapolis, Indiana, United States
RECRUITINGPharmacokinetics of Saroglitazar: Cmax
Maximum plasma concentration (Cmax)
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: Tmax
Time to reach maximum plasma concentration (Tmax)
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: AUCt
The area under plasma concentration vs. time curve till the last time point
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: AUCi
The area under plasma concentration vs. time curve extrapolated to the infinity
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: Kel
The elimination rate constant
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: AUCtau
The area under plasma concentration vs. time curve in a 48 hours dosing interval
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
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Pharmacokinetics of Saroglitazar: t1/2
The elimination half-life
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: Vd/F
The apparent volume of distribution
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: CL/F
The apparent clearance
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Number of participants with adverse events [Safety and Tolerability]
Number of participants with adverse events
Time frame: From baseline to End of study (35 days)
Pharmacokinetics of Saroglitazar sulfoxide: Tmax
Time to reach maximum plasma concentration
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: Cmax
Maximum plasma concentration
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: CL/F
The apparent clearance
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: Vd/F
The apparent volume of distribution
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: t1/2
The elimination half-life
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: AUCtau
The area under plasma concentration vs. time curve in a 48 hours dosing interval
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: Kel
The elimination rate constant
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: AUCi
The area under plasma concentration vs. time curve extrapolated to the infinity
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: AUCt
The area under plasma concentration vs. time curve extrapolated to the infinity
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Change from baseline in alkaline phosphatase levels
Time frame: From baseline to end of treatment (29 days)