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Effect of a Proton Pump Inhibitor on the Pharmacokinetics (PK) of Tepotinib

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ClinicalTrials.gov Identifier: NCT03531762
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Description
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Brief Summary:
This study will investigate in healthy subjects (i) the effect of omeprazole (proton pump inhibitor) co-administration on the single dose PK of tepotinib under fed conditions, and (ii) the effect of food on the single dose PK of tepotinib after co-administration of omeprazole and tepotinib. Furthermore, the study will assess the safety and tolerability of tepotinib alone and upon co-administration of omeprazole.

Condition or disease Intervention/treatment Phase
Healthy Drug: Tepotinib Drug: Omeprazole Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase I, Open-label, Three-Period Crossover Study to Investigate the Effect of a Proton Pump Inhibitor (Omeprazole) on the Pharmacokinetics of Tepotinib in Healthy Subjects
Actual Study Start Date : May 14, 2018
Actual Primary Completion Date : July 2, 2018
Actual Study Completion Date : July 2, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Sequence 1: Treatment A-B-C
Tepotinib alone in fed state (Treatment A) followed by Tepotinib in fasted state with omeprazole (Treatment B) followed by Tepotinib in fed state with omeprazole (Treatment C). Treatment periods will be separated by washout period of at least 14 days.
 Drug: Tepotinib
Participants will receive single oral dose of Tepotinib in Treatment Period A, B and C.

Drug: Omeprazole
Participants will receive omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment Period B and C.
Experimental: Sequence 2: Treatment A-C-B
Tepotinib alone in fed state (Treatment A) followed by Tepotinib in fed state with omeprazole (Treatment C) followed by Tepotinib in fasted state with omeprazole (Treatment B). Treatment periods will be separated by washout period of at least 14 days.
 Drug: Tepotinib
Participants will receive single oral dose of Tepotinib in Treatment Period A, B and C.

Drug: Omeprazole
Participants will receive omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment Period B and C.
Experimental: Sequence 3: Treatment B-A-C
Tepotinib in fasted state with omeprazole (Treatment B) followed by Tepotinib alone in fed state (Treatment A) followed by Tepotinib in fed state with omeprazole (Treatment C). Treatment periods will be separated by washout period of at least 14 days.
 Drug: Tepotinib
Participants will receive single oral dose of Tepotinib in Treatment Period A, B and C.

Drug: Omeprazole
Participants will receive omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment Period B and C.
Experimental: Sequence 4: Treatment B-C-A
Tepotinib in fasted state with omeprazole (Treatment B) followed by Tepotinib in fed state with omeprazole (Treatment C) followed by Tepotinib alone in fed state (Treatment A). Treatment periods will be separated by washout period of at least 14 days between.
 Drug: Tepotinib
Participants will receive single oral dose of Tepotinib in Treatment Period A, B and C.

Drug: Omeprazole
Participants will receive omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment Period B and C.
Experimental: Sequence 5: Treatment C-A-B
Tepotinib in fed state with omeprazole (Treatment C) followed by Tepotinib alone in fed state (Treatment A) followed by Tepotinib in fasted state with omeprazole (Treatment B). Treatment periods will be separated by washout period of at least 14 days.
 Drug: Tepotinib
Participants will receive single oral dose of Tepotinib in Treatment Period A, B and C.

Drug: Omeprazole
Participants will receive omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment Period B and C.
Experimental: Sequence 6: Treatment C-B-A
Tepotinib in fed state with omeprazole (Treatment C) followed by Tepotinib in fasted state with omeprazole (Treatment B) followed by Tepotinib alone in fed state (Treatment A). Treatment periods will be separated by washout period of at least 14 days.
 Drug: Tepotinib
Participants will receive single oral dose of Tepotinib in Treatment Period A, B and C.

Drug: Omeprazole
Participants will receive omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment Period B and C.


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Tepotinib (Treatment A) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  2. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Tepotinib (Treatment C) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  3. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tepotinib (Treatment A) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  4. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tepotinib (Treatment C) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  5. Maximum Observed Plasma Concentration (Cmax) of Tepotinib (Treatment A) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  6. Maximum Observed Plasma Concentration (Cmax) of Tepotinib (Treatment C) [ Time Frame: Pre-dose up to 144 hours post-dose ]

Secondary Outcome Measures :
  1. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Tepotinib (Treatment B) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  2. Maximum Observed Plasma Concentration (Cmax) of Tepotinib (Treatment B) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  3. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tepotinib (Treatment B) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  4. Time to Reach Maximum Plasma Concentration (Tmax) of Tepotinib (Treatments A, B and C) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  5. Elimination Half Time (t1/2) of Tepotinib (Treatments A, B and C) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  6. Time Prior to the First Measurable (non-zero) Concentration (tlag) of Tepotinib (Treatments A, B and C) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  7. Apparent Total Body Clearance (CL/f) of Tepotinib (Treatments A, B and C) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  8. Apparent Volume of Distribution During Terminal Phase (Vz/f) of Tepotinib (Treatments A, B and C) [ Time Frame: Pre-dose up to 144 hours post-dose ]
  9. Occurrence of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Day 18 ]
  10. Number of Participants With Clinically Significant Changes in Laboratory Assessments, 12-lead Electrocardiogram (ECG) Findings and Vital Signs [ Time Frame: Baseline up to Day 18 ]
    Number of participants with clinically significant changes will be reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy participants of non-child bearing potential
  • Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)
  • Body weight between 50 to 100 kilogram (kg)
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Participation in a clinical study within 60 days prior to first drug administration
  • Whole blood donation or loss of greater than (>) 450 milliliter (mL) within 60 days prior to first drug administration
  • Any surgical or medical condition, or any other significant disease that could interfere with the study objectives, conduct, or evaluation
  • Other protocol defined exclusion criteria could apply
Contacts and Locations
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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): NCT03531762


Locations
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Germany
Nuvisan GmbH
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
More Information
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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT03531762    
Other Study ID Numbers: MS200095_0039
2017-002832-18 ( EudraCT Number )
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck KGaA, Darmstadt, Germany:
Proton Pump Inhibitor
Omeprazole
Tepotinib
Non-small cell lung cancer (NSCLC)
Pharmacokinetics
Additional relevant MeSH terms:
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Tepotinib
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
 Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents