A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects with Severe Renal Impairment and Normal Renal Function

Exclusion Criteria

• •1. 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.
• •2. 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).
• •3. 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).
• •4. History of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the investigator.
• •5. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones) or other hepatic abnormalities that in the opinion of the investigator would preclude the subject from participation in the study.
• •6. Any major surgery within 3 months of screening.
• •7. Donation of blood or blood products within 3 months prior to screening.
• •8. Blood transfusion within 2 weeks of Day -1.
• •9. Current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
• •10. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 21 days prior to screening, unless deemed acceptable by the Investigator.
• •11. Receiving or has received any investigational drug within the 30 days or 5 halflives (whichever is longer), before receiving Saroglitazar Magnesium.
• •12. Group 2 (Normal renal function) subjects, who have a history of renal disease or renal injury as indicated by an abnormal BUN or creatinine at screening or Day-1.
• •13. Group 1 (Severe renal impairment) subjects, who have had a change in renal disease status within 30 days of screening, as documented by the participant's medical history and deemed clinically significant by the investigator.
• •14. For healthy renal function subjects, QT interval corrected for heart rate using Fridericia's method (QTcF) \> 450 msec, confirmed by repeat measurement. In renal impaired subjects QTcF \> 500 msec, confirmed by repeat measurement; no second or third degree AV block.
• •15. Group 1 subjects, who use or intend to use any over-the-counter (vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) or prescription medications within 30 days or 5 half-lives (whichever is longer) prior to enrollment, with the exception of hormone replacement therapy and therapies for renal disease and treatments of associated disorders that have been stable for at least 30 days prior to screening and until Day 1, unless deemed acceptable by the investigator (or designee).
• •16. Group 2 Subjects who have taken any prescription medications or over-the counter medications, including herbal products, within 14 days prior to start of study drug dosing, with the exception of vitamins, acetaminophen, hormonal contraceptive medications and/or any other over-the-counter product approved by the investigator.
• •17. Positive alcohol breath test at the time of check-in or those subjects who have current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance or subject safety.
• •18. Positive test for drugs of abuse at screening or admission, if not accounted by a prescription medication. Subjects with a positive test based on a prescribed medication may be enrolled.
• •19. Any subject with poor peripheral venous access.
• •20. Human immunodeficiency virus (HIV) type 1 antibody, HBsAg or HCV-Ab positive at screening.
• •1. History of nephrectomy or renal transplant
• •2. Any type of dialysis within 3 months prior to screening
• •3. Electrolyte abnormality or other screening laboratory value deemed clinically significant by investigator.