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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

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

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

NCT ID

NCT03546608

First Posted

May 23, 2018

Last Updated

August 22, 2022

Sponsor

EMD Serono Research & Development Institute, Inc.

Collaborators

Merck KGaA, Darmstadt, Germany

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

Data Monitoring Committee

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

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)

Learn more about this trial

Tepotinib Hepatic Impairment Trial

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