This study is currently not recruiting participants.

An open-label pharmacokinetic and tolerability study of eliglustat tartrate given as a single dose in subjects with mild and moderate hepatic impairment and in matched subjects with normal hepatic function STUDY NUMBER: POP13777

Study on Investigational Medication for Liver Function

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The purpose of this study is to investigate the pharmacokinetics of eliglustat in subjects with mild and moderate hepatic impairment, and to compare it to matched subjects with normal hepatic function to satisfy regulatory requirements.

Detailed description of study

The purpose of this study is to investigate the pharmacokinetics of eliglustat in subjects with mild and moderate hepatic impairment, and to compare it to matched subjects with normal hepatic function to satisfy regulatory requirements.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hepatic impairment
  • Age: 100 years or below
  • Gender: All

This study investigates the way an investigational medication is processed in the body in people with liver problems. The study will look at people with mild and moderate liver issues and compare them to people with normal liver function.

Participants will receive the investigational medication and undergo tests to see how their bodies process the medication. This involves checking how the medication is absorbed, distributed, and eliminated from the body.

  • Who can participate: Participants aged 18 and older should have either mild or moderate liver function impairment or normal liver function for comparison.
  • Study details: Participants will take the investigational medication and have tests to measure how their bodies handle the medication.
Updated on 19 Feb 2024. Study ID: 1508673730

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