Tepotinib Hepatic Impairment Trial

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Tepotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03546608

MS200095_0028

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Healthy Participants (Control)

Experimental group

Description:

Participants with normal hepatic function matched to moderate hepatic impairment received single oral dose of 500 milligrams (mg) of tepotinib film-coated tablet on Day 1 after a standard breakfast.

Treatment:

Drug: Tepotinib

Mild Hepatic Impairment (Child-Pugh Class A)

Experimental group

Description:

Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 500 mg tepotinib film-coated tablet on Day 1 after a standard breakfast.

Treatment:

Drug: Tepotinib

Moderate Hepatic Impairment (Child-Pugh Class B)

Experimental group

Description:

Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 500 mg tepotinib film-coated tablet on Day 1 after a standard breakfast.

Treatment:

Drug: Tepotinib