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New treatment option for Hepatic Impairment
Official title Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
ClinicalTrials.gov ID: NCT05045482
What this study is testing
What is Saroglitazar Magnesium 1 mg?
Saroglitazar Magnesium 1 mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for hepatic impairment.
Also referred to as Subjects will be domicile in clinic from Day -1 till Day 5 or Day 7 and from Day 27 through day 29 for PK sampling procedures..
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- For all people:
- 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...
You likely can't join if
- For all people:
- Any significant, unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the...
- 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...
- History of stomach or intestinal surgery or resection within the six months prior to screening that would potentially alter absorption and/or...
- History of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the Investigator.
- Any major surgery within 3 months of screening.
See the full eligibility criteria
- For all people:
- 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.
- Females of child-bearing potential and males must agree to use contraception for the full duration of the study.
- Ability to swallow and retain oral medication. For people in Groups 8 and 9 (Hepatic impairment group but with cirrhosis from cholestatic liver disease):
- 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...
- Laboratory test values for hepatic impairment people 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:
- ALT/AST value ≤ 10 × upper limit of normal (ULN)
- Absolute neutrophil count (ANC) ≥ 750/mm3
- Platelets ≥ 25,000/mm3
- Hemoglobin ≥ 8 g/dL
- α-fetoprotein \< 50 ng/mL or 50-80 ng/mL with negative imaging study (US, CT, MRI). For people in Groups 8D and 9D (normal hepatic function groups):
- people 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...
- Laboratory test values within normal limits or considered not clinically significant by the Investigator for people with normal hepatic function including ALT/AST \< 1.2 × ULN at screening.
- For all people:
- 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...
- 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...
- History of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the Investigator.
- Any major surgery within 3 months of screening.
- Donation of blood or blood products within 3 months prior to screening.
- Current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within the two weeks prior to screening.
- 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...
- Receiving or has received any investigational drug within the 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.
- Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 by modification of diet in renal disease (MDRD) formula at screening.
- Positive alcohol breath test at the time of check-in or those people who have current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance or subject safety.
- Positive test for drugs of abuse at screening or admission. people with a positive test based on a prescribed medication may be enrolled.
- Any subject with poor peripheral venous access
- Receipt of blood products within 1 month prior to check in.
- Human immunodeficiency virus (HIV) type 1 antibody positive at screening for all groups. For people in Groups 8 and 9 (Hepatic impairment group but with cirrhosis from cholestatic liver disease):
- 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.
- people 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.
- people having -
- History of gastrointestinal bleeding within 1 month prior to screening.
- Current functioning organ transplant.
- Evidence of severe ascites requiring frequent paracentesis in the opinion of investigator.
- people 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...
- Total bilirubin \> 5×ULN For Control with Normal Hepatic Function:
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.