Tepotinib Hepatic Impairment Trial
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
The study investigated the effect of various degrees of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of tepotinib.
Key facts
- Study ID
- NCT03546608
- Run by
- EMD Serono Research & Development Institute, Inc.
- People needed
- 18
- Starts
- 2018-06-13
- Expected to finish
- 2019-02-05
- Last updated by the study team
- 2024-08-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Men and women (of nonchildbearing potential), with a body mass index of 18 to 36 kilograms per meter square (inclusive) and a body weight greater than or equal to 50 kilograms at screening, with the absence of acute hepatitis or Human Immunodeficiency Virus 1 and 2, who gave informed consent and are willing and able to comply with study procedures were eligible for enrollment
- Participants with impaired hepatic function (Child-Pugh class A or Child-Pugh class B) and participants with normal hepatic function were eligible to enroll in the study
- Other protocol defined inclusion criteria could apply
You may not qualify if…
- Healthy participants were excluded if they have hepatitis B or C or had a previous infection with hepatitis C treated with Sofosbuvir or other antiviral compounds, or any other clinically relevant disease, as considered by the Investigator
- Participants with impaired hepatic function were excluded if they have primary biliary liver cirrhosis, nonstabilized chronic heart failure, hepatocarcinoma, hepatic encephalopathy (Grade III or IV), sepsis or gastrointestinal bleeding, or any other clinically relevant disease, as considered by the Investigator
- Other protocol defined exclusion criteria could apply
Where it is running
- Qps Mra, Llc — Miami, Florida, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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