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Tepotinib Hepatic Impairment Trial

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ClinicalTrials.gov Identifier: NCT03546608
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

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

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: Tepotinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 13, 2018
Actual Primary Completion Date : February 5, 2019
Actual Study Completion Date : February 5, 2019

Arm Intervention/treatment
Experimental: Part 1, Child-Pugh Class A: Tepotinib Drug: Tepotinib
Participants will receive a single oral dose of tepotinib in Part 1.

Experimental: Part 1, Child-Pugh Class B: Tepotinib Drug: Tepotinib
Participants will receive a single oral dose of tepotinib in Part 1.

Experimental: Part 1, Healthy Participants: Tepotinib
Healthy participants matched to Child-Pugh Class B participants.
Drug: Tepotinib
Participants will receive a single oral dose of tepotinib in Part 1.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Maximum Observed Plasma Concentration (Cmax) of Tepotinib [ Time Frame: Pre-dose up to Day 22 ]

Secondary Outcome Measures :
  1. Time to Reach the Maximum Plasma Concentration (tmax) of Tepotinib [ Time Frame: Pre-dose up to Day 22 ]
  2. Terminal Half-Life (t1/2) of Tepotinib [ Time Frame: Pre-dose up to Day 22 ]
  3. Apparent Total Body Clearance of Tepotinib From Plasma Following Oral Administration (CL/f) [ Time Frame: Pre-dose up to Day 22 ]
  4. Apparent Volume of Distribution of Tepotinib During the Terminal Phase Following Extravascular Administration (VZ/f) [ Time Frame: Pre-dose up to Day 22 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. Maximum Observed Plasma Concentration (Cmax) of Tepotinib Metabolites MSC2571109 and MSC2571107 [ Time Frame: Pre-dose up to Day 22 ]
  9. Time to Reach the Maximum Plasma Concentration (tmax) of Tepotinib Metabolites MSC2571109 and MSC2571107 [ Time Frame: Pre-dose up to Day 22 ]
  10. Terminal Half-Life (t1/2) of Tepotinib Metabolites MSC2571109 and MSC2571107 [ Time Frame: Pre-dose up to Day 22 ]
  11. 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 ]
  12. Tepotinib Metabolites (MSC2571109 or MSC2571107) AUC 0-inf to tepotinib AUC 0-inf ratio (MRAUC0-inf) [ Time Frame: Pre-dose up to Day 22 ]
  13. Tepotinib Metabolites (MSC2571109 or MSC2571107) Cmax to tepotinib Cmax ratio (MRCmax) [ Time Frame: Pre-dose up to Day 22 ]
  14. Occurrences of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to Day 22 ]
  15. Number of Subjects With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings [ Time Frame: Day 1 up to Day 22 ]
    Number of subjects with clinically significant abnormalities will be reported.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546608


Locations
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United States, Florida
Qps Mra, Llc
Miami, Florida, United States, 33143
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible EMD Serono Research & Development Institute, Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany
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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT03546608    
Other Study ID Numbers: MS200095_0028
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Hepatic Impairment
Tepotinib
Pharmacokinetics
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases