Tepotinib Hepatic Impairment Trial

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546608
• Other study ID #: MS200095_0028
• Status: Completed
• Phase: Phase 1
• Start date: June 13, 2018
• Est. completion date: February 5, 2019

Study information

• Verified date: August 2022
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 5, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Tepotinib
Participants will receive a single oral dose of tepotinib in Part 1.

Locations

Country	Name	City	State
United States	Qps Mra, Llc	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono Research & Development Institute, Inc.	Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC 0-t) of Tepotinib		Pre-dose up to Day 22
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Tepotinib		Pre-dose up to Day 22
Primary	Maximum Observed Plasma Concentration (Cmax) of Tepotinib		Pre-dose up to Day 22
Secondary	Time to Reach the Maximum Plasma Concentration (tmax) of Tepotinib		Pre-dose up to Day 22
Secondary	Terminal Half-Life (t1/2) of Tepotinib		Pre-dose up to Day 22
Secondary	Apparent Total Body Clearance of Tepotinib From Plasma Following Oral Administration (CL/f)		Pre-dose up to Day 22
Secondary	Apparent Volume of Distribution of Tepotinib During the Terminal Phase Following Extravascular Administration (VZ/f)		Pre-dose up to Day 22
Secondary	Area Under the Plasma Concentration-Time Curve Extrapolated From Time t to Infinity as a Percentage of AUC 0-inf (AUC extra%) of Tepotinib		Pre-dose up to Day 22
Secondary	Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC 0-t) of Tepotinib Metabolites MSC2571109 and MSC2571107		Pre-dose up to Day 22
Secondary	Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Tepotinib Metabolites MSC2571109 and MSC2571107		Pre-dose up to Day 22
Secondary	Maximum Observed Plasma Concentration (Cmax) of Tepotinib Metabolites MSC2571109 and MSC2571107		Pre-dose up to Day 22
Secondary	Time to Reach the Maximum Plasma Concentration (tmax) of Tepotinib Metabolites MSC2571109 and MSC2571107		Pre-dose up to Day 22
Secondary	Terminal Half-Life (t1/2) of Tepotinib Metabolites MSC2571109 and MSC2571107		Pre-dose up to Day 22
Secondary	Area Under the Plasma Concentration-time Curve Extrapolated From Time t to Infinity as a Percentage of AUC 0-inf (AUC extra%) of Tepotinib Metabolites MSC2571109 and MSC2571107		Pre-dose up to Day 22
Secondary	Tepotinib Metabolites (MSC2571109 or MSC2571107) AUC 0-inf to tepotinib AUC 0-inf ratio (MRAUC0-inf)		Pre-dose up to Day 22
Secondary	Tepotinib Metabolites (MSC2571109 or MSC2571107) Cmax to tepotinib Cmax ratio (MRCmax)		Pre-dose up to Day 22
Secondary	Occurrences of Treatment-emergent Adverse Events (TEAEs)		Day 1 up to Day 22
Secondary	Number of Subjects With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings	Number of subjects with clinically significant abnormalities will be reported.	Day 1 up to Day 22

External Links

•   Redacted Clinical study report, redacted clinical study protocol and redacted statistical analysis plan for this study is also available at the HC-PRCI portal (Health Canada-Public release of clinical information)