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Tepotinib Hepatic Impairment Trial

Primary Purpose

Hepatic Impairment

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tepotinib
Sponsored by
EMD Serono Research & Development Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatic Impairment focused on measuring Hepatic Impairment, Tepotinib, Pharmacokinetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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 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

Sites / Locations

  • Qps Mra, Llc
  • Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 1, Child-Pugh Class A: Tepotinib

Part 1, Child-Pugh Class B: Tepotinib

Part 1, Healthy Participants: Tepotinib

Arm Description

Healthy participants matched to Child-Pugh Class B participants.

Outcomes

Primary Outcome Measures

Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC 0-t) of Tepotinib
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Tepotinib
Maximum Observed Plasma Concentration (Cmax) of Tepotinib

Secondary Outcome Measures

Time to Reach the Maximum Plasma Concentration (tmax) of Tepotinib
Terminal Half-Life (t1/2) of Tepotinib
Apparent Total Body Clearance of Tepotinib From Plasma Following Oral Administration (CL/f)
Apparent Volume of Distribution of Tepotinib During the Terminal Phase Following Extravascular Administration (VZ/f)
Area Under the Plasma Concentration-Time Curve Extrapolated From Time t to Infinity as a Percentage of AUC 0-inf (AUC extra%) of Tepotinib
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC 0-t) of Tepotinib Metabolites MSC2571109 and MSC2571107
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Tepotinib Metabolites MSC2571109 and MSC2571107
Maximum Observed Plasma Concentration (Cmax) of Tepotinib Metabolites MSC2571109 and MSC2571107
Time to Reach the Maximum Plasma Concentration (tmax) of Tepotinib Metabolites MSC2571109 and MSC2571107
Terminal Half-Life (t1/2) of Tepotinib Metabolites MSC2571109 and MSC2571107
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
Tepotinib Metabolites (MSC2571109 or MSC2571107) AUC 0-inf to tepotinib AUC 0-inf ratio (MRAUC0-inf)
Tepotinib Metabolites (MSC2571109 or MSC2571107) Cmax to tepotinib Cmax ratio (MRCmax)
Occurrences of Treatment-emergent Adverse Events (TEAEs)
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.

Full Information

First Posted
May 23, 2018
Last Updated
August 22, 2022
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03546608
Brief Title
Tepotinib Hepatic Impairment 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
February 5, 2019 (Actual)
Study Completion Date
February 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
Keywords
Hepatic Impairment, Tepotinib, Pharmacokinetics

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1, Child-Pugh Class A: Tepotinib
Arm Type
Experimental
Arm Title
Part 1, Child-Pugh Class B: Tepotinib
Arm Type
Experimental
Arm Title
Part 1, Healthy Participants: Tepotinib
Arm Type
Experimental
Arm Description
Healthy participants matched to Child-Pugh Class B participants.
Intervention Type
Drug
Intervention Name(s)
Tepotinib
Intervention Description
Participants will receive a single oral dose of tepotinib in Part 1.
Primary Outcome Measure Information:
Title
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC 0-t) of Tepotinib
Time Frame
Pre-dose up to Day 22
Title
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Tepotinib
Time Frame
Pre-dose up to Day 22
Title
Maximum Observed Plasma Concentration (Cmax) of Tepotinib
Time Frame
Pre-dose up to Day 22
Secondary Outcome Measure Information:
Title
Time to Reach the Maximum Plasma Concentration (tmax) of Tepotinib
Time Frame
Pre-dose up to Day 22
Title
Terminal Half-Life (t1/2) of Tepotinib
Time Frame
Pre-dose up to Day 22
Title
Apparent Total Body Clearance of Tepotinib From Plasma Following Oral Administration (CL/f)
Time Frame
Pre-dose up to Day 22
Title
Apparent Volume of Distribution of Tepotinib During the Terminal Phase Following Extravascular Administration (VZ/f)
Time Frame
Pre-dose up to Day 22
Title
Area Under the Plasma Concentration-Time Curve Extrapolated From Time t to Infinity as a Percentage of AUC 0-inf (AUC extra%) of Tepotinib
Time Frame
Pre-dose up to Day 22
Title
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC 0-t) of Tepotinib Metabolites MSC2571109 and MSC2571107
Time Frame
Pre-dose up to Day 22
Title
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Tepotinib Metabolites MSC2571109 and MSC2571107
Time Frame
Pre-dose up to Day 22
Title
Maximum Observed Plasma Concentration (Cmax) of Tepotinib Metabolites MSC2571109 and MSC2571107
Time Frame
Pre-dose up to Day 22
Title
Time to Reach the Maximum Plasma Concentration (tmax) of Tepotinib Metabolites MSC2571109 and MSC2571107
Time Frame
Pre-dose up to Day 22
Title
Terminal Half-Life (t1/2) of Tepotinib Metabolites MSC2571109 and MSC2571107
Time Frame
Pre-dose up to Day 22
Title
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
Time Frame
Pre-dose up to Day 22
Title
Tepotinib Metabolites (MSC2571109 or MSC2571107) AUC 0-inf to tepotinib AUC 0-inf ratio (MRAUC0-inf)
Time Frame
Pre-dose up to Day 22
Title
Tepotinib Metabolites (MSC2571109 or MSC2571107) Cmax to tepotinib Cmax ratio (MRCmax)
Time Frame
Pre-dose up to Day 22
Title
Occurrences of Treatment-emergent Adverse Events (TEAEs)
Time Frame
Day 1 up to Day 22
Title
Number of Subjects With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings
Description
Number of subjects with clinically significant abnormalities will be reported.
Time Frame
Day 1 up to Day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
EMD Serono Research & Development Institute, Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Qps Mra, Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States

12. IPD Sharing Statement

Links:
URL
https://clinical-information.canada.ca/ci-rc/item/242300
Description
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)

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Tepotinib Hepatic Impairment Trial

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