Tepotinib Hepatic Impairment Trial



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:8/26/2018
Start Date:June 13, 2018
End Date:September 21, 2018
Contact:US Medical Information
Email:service@emdgroup.com
Phone:888-275-7376

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Open-Label, Parallel-Group Phase 1 Study to Investigate the Effect of Various Degrees of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of the c-Met Kinase Inhibitor Tepotinib

The study will investigate the effect of various degrees of hepatic impairment on the
pharmacokinetics (PK), safety and tolerability of tepotinib.


Inclusion Criteria:

- 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 have given informed consent and are willing and able to comply with
study procedures will be eligible for enrollment

- Participants with impaired hepatic function (Child-Pugh class A or Child-Pugh class B)
and participants with normal hepatic function will be eligible to enroll in the study

- Other protocol defined inclusion criteria could apply

Exclusion Criteria:

- Healthy participants will be 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 will be 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
We found this trial at
2
sites
Miami, Florida 33243
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Orlando, FL
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