Healthy Volunteers Needed for Liver Disease Study!

Study Overview

Are you between the ages of 18-80 and are in overall good health?     WE NEED YOUR HELP!
 
Researchers at the Indiana University School of Medicine are looking for healthy volunteers with normal liver functions to take part in a study to help determine the safety and effectiveness of a new investigational drug called Saroglitazar.
 
Liver impairment or disease may change how a drug would normally work in the human body. The blood levels of participants with liver disease will be compared to participants with normal liver functions to see how this drug is processed by the liver in the body. 

Study Description

Who is Eligible
  • Ages 18-80 (if female, must not be pregnant or breast-feeding)
  • Must have no current liver disease
  • In general overall good health
  • Must be willing to attend multiple study visits (including two overnight visits) at University Hospital in Indianapolis, IN
What is Involved
For this study, you will be asked to attend an in-person screening visit to see if you qualify. 
Must be willing to attend multiple study visits (including two overnight visits) at University Hospital in Indianapolis, IN
 
If you are eligible and choose to participate, you will be asked to attend 5 in-person study visits at Indiana University Hospital in Indianapolis over a period of approx. 2 months (this includes up to 4 overnight visits).  Study visits will last about 3 hours.
 
Study visits will include the following:
  • Review of medical history and demographics information
  • Measurements of height, weight and vital signs (such as blood pressure and heart rate)
  • ECG (patches will be placed on your chest, arms and legs to record your heart's electrical activity)
  • Urine drug screen and alcohol breath analysis
  • Blood and urine samples will be collected
Compensation/Benefits of Participating
  • You will receive $250 for each overnight study visit and $75 (plus mileage) for each out-patient study visit
How to Participate
**Please reach out to the study team directly by contacting:
 Mandy Cruz, Study Coordinator, at email mandcruz@iu.edu or by phone at (317) 278-6215 or
Kayte Sutton, Study Assistant, at email kpsutton@iu.edu or by phone at (317) 278-4554
 
Thank you for your interest in our study!!

Additional Information

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


  • IRB Number: 2007967518
  • Research Study Identifier: TX11511
  • Principal Investigator: Raj Vuppalanchi, MD

Recruitment Status

Open

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Contact Us

If you need help finding a study or have any questions, please contact us at inhealth@iu.edu or by phone at (888) 264-0005.