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Tests treatment safety and results for Cholestatic Liver Disease
Official title Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
ClinicalTrials.gov ID: NCT06825559
What this study is testing
What is Saroglitazar Magnesium 1 mg?
Saroglitazar Magnesium 1 mg is an investigational medicine, being studied as a potential treatment for cholestatic liver disease.
Also referred to as Not any.
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
- 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
- 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
You may be able to join if
- Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF.
- Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
- Ability to swallow and retain oral medication.
- people having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease having Child-Pugh Turcotte score 7 to 9. If...
- Laboratory test values must be clinically acceptable to the investigator and meet all the following parameters at screening: Alkaline Phosphatase \>...
You likely can't join if
- Any significant or unstable medical condition or other instability that would prevent the subject from participating in the study as determined by...
- 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 6 months of screening that would potentially alter absorption and/or excretion of orally...
- The 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 of screening.
See the full eligibility criteria
- Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF.
- Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
- Ability to swallow and retain oral medication.
- people having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease having Child-Pugh Turcotte score 7 to 9. If the hepatic impairment classification for the subject is not the same at...
- Laboratory test values must be clinically acceptable to the investigator and meet all the following parameters at screening: Alkaline Phosphatase \> upper limit of normal Alanine aminotransferase/Aspartate...
- Must provide written informed consent and agree to comply with the trial protocol.
- Any significant or unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the investigator
- 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 6 months of screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and...
- The 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 of screening.
- Active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within 2 weeks of screening.
- Receiving or has received any investigational drug within 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.
- Estimated glomerular filtration rate (\<45 mL/min/1.73 m2 by CKD-EPI 2021 formula at screening.
- Any individual with poor peripheral venous access.
- Receipt of blood products within 1 month of check in.
- Human immunodeficiency virus type 1 antibody positive at screening.
- Other known causes of liver disease, such as non-alcoholic steatohepatitis , alcoholic steatohepatitis, autoimmune hepatitis, or acute or chronic viral hepatitis (including Hepatitis B and C) as determined by the...
- people who have had a change in hepatic disease status within 30 days of screening, as documented by the subject's medical history and deemed clinically significant by the investigator.
- people having - History of gastrointestinal bleeding within 1 month of screening. Current functioning organ transplant. Evidence of severe ascites requiring frequent paracentesis in the opinion of the investigator.
- Pregnancy-related exclusions, including: Pregnant/lactating female (including positive pregnancy test at screening) Pregnancy should be avoided by male and female people either by true abstinence or the use of an...
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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. 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.