Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZydus Therapeutics Inc.
About this trial
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ability to comprehend and willingness to sign a written ICF for the study.
Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF.
Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study.
Disqualifiers
Any significant, unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the Investigator or designee.
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 the six months prior to screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
History of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the Investigator.
Trial design
Design model
Parallel
Treatments tested in this trial
Saroglitazar Magnesium 1 mg
DrugGroup-8: Total of 18 subjects will be enrolled in the Group-8. Group 8A (n=6, consist of mild hepatic impairment subjects); Group 8B (n=6, consist of moderate hepatic impairment), Group 8C (n=3, consist of severe hepatic impairment and Group 8D (n=3, consist of control subjects with normal hepatic functions).
Saroglitazar Magnesium 2 mg
DrugGroup-9: Total of 12 subjects will be enrolled in the Group-9. Group 9A (n=3, consist of mild hepatic impairment subjects); Group 9B (n=3, consist of moderate hepatic impairment), Group 9C (n=3, consist of severe hepatic impairment and Group 9D (n=3, consist of control subjects with normal hepatic functions).
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Saroglitazar Magnesium 1 mgExperimental treatment 1 intervention
Group B: Saroglitazar Magnesium 2 mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the plasma PK of Saroglitazar (parent compound)
To measure the plasma concentration of Saroglitazar (parent compound) and estimate the AUCt following single and once a daily multiple oral doses of 1 mg and 2 mg in subjects with mild, moderate and severe hepatic impairment with cirrhosis due to cholestatic liver disease based on Child-Pugh-Turcotte score compared to subjects with normal hepatic function.
Time frame
Serial PK blood samples will be collected on Day1 and Day 28 (1 pre-dose sample and serial post dose sampling till 24 hours post dose on both days)2
To assess the safety and tolerability of Saroglitazar
Percentage of subjects with clinical \& laboratory AEs/SAEs and Treatment emergent AEs/SAEs, coded using the MedDRA following single and once a daily multiple oral doses of 1 mg and 2 mg of Saroglitazar Magnesium in subjects with mild, moderate and severe hepatic impairment with cirrhosis due to cholestatic liver disease based on Child-Pugh-Turcotte score compared to subjects with normal hepatic function
Time frame
Through study completion, an average of 9 weeks3
To evaluate plasma PK of Saroglitazar metabolite (Saroglitazar sulfoxide)
To measure the plasma concentration of Saroglitazar metabolite (Saroglitazar sulfoxide) and estimate the AUCt following single and once a daily multiple oral doses of 1 mg and 2 mg in subjects with mild, moderate and severe hepatic impairment with cirrhosis due to cholestatic liver disease based on Child-Pugh-Turcotte score compared to subjects with normal hepatic function.
Time frame
Serial PK blood samples will be collected on Day 1 and Day 28 (1 pre-dose sample and serial post dose sampling till 24 hours post dose on both days)4
To evaluate the impact of hepatic impairment with cirrhosis due to cholestatic liver disease on the unbound concentration of Saroglitazar in systemic circulation
To measure the differences (between day-01 and Day-28) on unbound concentration of Saroglitazar in systemic circulation following single and once a daily multiple oral doses of 1 mg and 2 mg in subjects with mild, moderate and severe hepatic impairment with cirrhosis due to cholestatic liver disease based on Child-Pugh-Turcotte score compared to subjects with normal hepatic function
Time frame
The blood samples will be collected on Day 1 and Day 28 at pre-dose, 2.0 h and 24.0 h post dose.Sponsors and contacts
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Source ClinicalTrials.gov