RECRUITING

Hepatic Impairment with Cirrhosis Due to Cholestatic Liver Disease

Conditions

Hepatic Impairment Cirrhosis Cholestatic Liver Disease Saroglitazar Magnesium

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease

Official Title

A Phase 1, Open-label Extension Groups Study in Subjects Having Hepatic Impairment with Cirrhosis Due to Cholestatic Liver Disease

Quick Facts

Study Start:2021-10-21

Study Completion:2024-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05045482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Ability to comprehend and willingness to sign a written ICF for the study. 2. Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF. 3. Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening. 4. Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study. 5. Females of child-bearing potential and males must agree to use contraception for the full duration of the study. 6. Ability to swallow and retain oral medication. 7. Participants having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease in Groups 8 and 9 will be classified in sub groups at screening based on CPT score. 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 hepatology Investigator. 8. Laboratory test values for hepatic impairment subjects Groups 8 (8A, 8B, 8C) and 9 (9A, 9B, 9C) must be clinically acceptable to the Investigator and meet all the following parameters at Screening: 1. ALT/AST value ≤ 10 × upper limit of normal (ULN) 2. Absolute neutrophil count (ANC) ≥ 750/mm3 3. Platelets ≥ 25,000/mm3 4. Hemoglobin ≥ 8 g/dL 5. α-fetoprotein \< 50 ng/mL or 50-80 ng/mL with negative imaging study (US, CT, MRI). 9. Subjects should be in good health as determined by no clinically significant findings in the medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), or laboratory examinations at Screening or Check-in. 10. Laboratory test values within normal limits or considered not clinically significant by the Investigator for subjects with normal hepatic function including ALT/AST \< 1.2 × ULN at screening.	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. Any major surgery within 3 months of screening. 6. Donation of blood or blood products within 3 months prior to screening. 7. Current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within the two weeks prior to screening. 8. 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. 9. Receiving or has received any investigational drug within the 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium. 10. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 by modification of diet in renal disease (MDRD) formula at screening. 11. 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. 12. Positive test for drugs of abuse at screening or admission. Subjects with a positive test based on a prescribed medication may be enrolled. 13. Any subject with poor peripheral venous access 14. Receipt of blood products within 1 month prior to check in. 15. Human immunodeficiency virus (HIV) type 1 antibody positive at screening for all groups. 16. Other known cause of liver disease such as NASH, alcoholic steatohepatitis (ASH), autoimmune hepatitis, or acute or chronic viral hepatitis as determined by the Investigator and subject's medical records. 17. Subjects who have had a change in hepatic disease status within 30 days of screening, as documented by the participant's medical history and deemed clinically significant by the Investigator. 18. Subjects having - 1. History of gastrointestinal bleeding within 1 month prior to screening. 2. Current functioning organ transplant. 3. Evidence of severe ascites requiring frequent paracentesis in the opinion of investigator. 19. 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 enrolment, with the exception of hormone replacement therapy and therapies for hepatic 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). 20. 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.

Inclusion Criteria

Exclusion Criteria

1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF.
3. Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
4. Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study.
5. Females of child-bearing potential and males must agree to use contraception for the full duration of the study.
6. Ability to swallow and retain oral medication.
7. Participants having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease in Groups 8 and 9 will be classified in sub groups at screening based on CPT score. 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 hepatology Investigator.
8. Laboratory test values for hepatic impairment subjects Groups 8 (8A, 8B, 8C) and 9 (9A, 9B, 9C) must be clinically acceptable to the Investigator and meet all the following parameters at Screening:
1. ALT/AST value ≤ 10 × upper limit of normal (ULN)
2. Absolute neutrophil count (ANC) ≥ 750/mm3
3. Platelets ≥ 25,000/mm3
4. Hemoglobin ≥ 8 g/dL
5. α-fetoprotein \< 50 ng/mL or 50-80 ng/mL with negative imaging study (US, CT, MRI).
9. Subjects should be in good health as determined by no clinically significant findings in the medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), or laboratory examinations at Screening or Check-in.
10. Laboratory test values within normal limits or considered not clinically significant by the Investigator for subjects with normal hepatic function including ALT/AST \< 1.2 × ULN at screening.

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. Any major surgery within 3 months of screening.
6. Donation of blood or blood products within 3 months prior to screening.
7. Current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within the two weeks prior to screening.
8. 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.
9. Receiving or has received any investigational drug within the 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.
10. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 by modification of diet in renal disease (MDRD) formula at screening.
11. 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.
12. Positive test for drugs of abuse at screening or admission. Subjects with a positive test based on a prescribed medication may be enrolled.
13. Any subject with poor peripheral venous access
14. Receipt of blood products within 1 month prior to check in.
15. Human immunodeficiency virus (HIV) type 1 antibody positive at screening for all groups.
16. Other known cause of liver disease such as NASH, alcoholic steatohepatitis (ASH), autoimmune hepatitis, or acute or chronic viral hepatitis as determined by the Investigator and subject's medical records.
17. Subjects who have had a change in hepatic disease status within 30 days of screening, as documented by the participant's medical history and deemed clinically significant by the Investigator.
18. Subjects having -
1. History of gastrointestinal bleeding within 1 month prior to screening.
2. Current functioning organ transplant.
3. Evidence of severe ascites requiring frequent paracentesis in the opinion of investigator.
19. 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 enrolment, with the exception of hormone replacement therapy and therapies for hepatic 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).
20. 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.

Contacts and Locations

Study Contact

Farheen Shaikh

CONTACT

+1 6094534751

fshaikh@zydustherapeutics.com

Principal Investigator

Deven V Parmar, MD, FCP

STUDY_DIRECTOR

Zydus Therapeutics Inc.

Study Locations (Sites)

Zydus US002

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Zydus Therapeutics Inc.

Deven V Parmar, MD, FCP, STUDY_DIRECTOR, Zydus Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-21

Study Completion Date2024-11-30

Study Record Updates

Study Start Date2021-10-21

Study Completion Date2024-11-30

Terms related to this study

Keywords Provided by Researchers

Hepatic Impairment
Saroglitazar Magnesium
Cirrhosis
Cholestatic Liver Disease

Additional Relevant MeSH Terms

Hepatic Impairment
Cirrhosis
Cholestatic Liver Disease