HealthyPhase 1NCT03629223

Bioequivalence of TF3 and TF2 and Effect of Food on the PK of Tepotinib

A Phase 1 study testing Tepotinib TF2 and Tepotinib TF3 in people with Healthy, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of the study was to demonstrate bioequivalence between the new tablet formulation (TF3, test treatment) and the tablet formulation used in clinical studies (TF2, reference treatment) and to investigate effect of food on pharmacokinetics (PK) of tepotinib. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Tepotinib TF2 and Tepotinib TF3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteGermany
Study dates: 23 Aug 2018to 25 Jan 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Nuvisan GmbH
Neu-Ulm, 89231

Other trials in Germany

About this study

Official title: Phase 1, Open-label, 3-Parts Study With Crossover Design in Each Part to Investigate the Bioequivalence of the Tablet Formulation of TF3 Compared to TF2 (Part A), and to Investigate the Influence of Food on the PK of Each TF2 (Part B) and TF3 (Part C) of Tepotinib in Healthy Subjects

Conditions: Healthy
Being tested: Tepotinib TF2, Tepotinib TF3
Keywords: Tepotinib, Pharmacokinetics, Bioequivalence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tepotinib TF2Drug
Participants received a single oral dose of 500 mg Tepotinib TF2 under fasting or fed conditions in treatment period 1 or 2.
Tepotinib TF3Drug
Participants received single oral dose of 500 mg (2 x 250 mg)Tepotinib TF3 under fasting or fed conditions in treatment period 1 or 2.

Study groups in NCT03629223
Study group	Role	What they receive
Part A: First Tepotinib TF2 then TF3	Experimental	Participants received a single oral dose of 500 milligrams (mg) Tepotinib tablet formulation 2 (TF2, reference treatment) on Day 1 of treatment period 1 followed by a single oral dose of 500 mg (2 x 250 mg) Tepotinib tablet formulation 3 (TF3, test treatment) on Day 1 of treatment period 2 under fasting conditions. The washout period was 21 days between Day 1 of each period. Receives: Drug: Tepotinib TF2; Drug: Tepotinib TF3
Part A: First Tepotinib TF3 then TF2	Experimental	Participants received a single oral dose of 500 mg (2 x 250 mg) Tepotinib TF3 (test treatment) on Day 1 of treatment period 1 followed by a single oral dose of 500 mg Tepotinib TF2 (reference treatment) on Day 1 of treatment period 2 under fasting conditions. The washout period was 21 days between Day 1 of each period. Receives: Drug: Tepotinib TF2; Drug: Tepotinib TF3
Part B: First Tepotinib TF2 Fasted then TF2 Fed	Experimental	Participants received a single oral dose of 500 mg Tepotinib TF2 (reference treatment) on Day 1 of treatment period 1 under fasting conditions followed by a single oral dose of 500 mg Tepotinib TF2 (reference treatment) on Day 1 of treatment period 2 under fed conditions. The washout period was 21 days between Day 1 of each period. Receives: Drug: Tepotinib TF2
Part B: First Tepotinib TF2 Fed then TF2 Fasted	Experimental	Participants received a single oral dose of 500 mg Tepotinib TF2 (reference treatment) on Day 1 of treatment period 1 under fed conditions followed by a single oral dose of 500 mg Tepotinib TF2 (reference treatment) on Day 1 of treatment period 2 under fasting conditions. The washout period was 21 days between Day 1 of each period. Receives: Drug: Tepotinib TF2
Part C: First Tepotinib TF3 Fasted then TF3 Fed	Experimental	Participants received a single oral dose of 500 mg (2 x 250 mg) Tepotinib TF3 (test treatment) on Day 1 of treatment period 1 under fasting conditions followed by a single oral dose of 500 mg (2 x 250 mg) Tepotinib TF3 (test treatment) on Day 1 of treatment period 2 under fed conditions. The washout period was 21 days between Day 1 of each period. Receives: Drug: Tepotinib TF3
Part C: First Tepotinib TF3 Fed then TF3 Fasted	Experimental	Participants received a single oral dose of 500 mg (2 x 250 mg) Tepotinib TF3 (test treatment) on Day 1 of treatment period 1 under fed conditions followed by a single oral dose of 500 mg (2 x 250 mg) Tepotinib TF3 (test treatment) on Day 1 of treatment period 2 under fasting conditions. The washout period was 21 days between Day 1 of each period. Receives: Drug: Tepotinib TF3

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A, B and C: 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 versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
Part A, B and C: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Tepotinib
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ lambda z, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and lambda z is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
Part A, B and C: Maximum Observed Plasma Concentration (Cmax) of Tepotinib
Cmax was obtained directly from the concentration versus time curve.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period

Secondary outcomes (8)

Part A, B and C: Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
Part A, B and C: Terminal Half-Life (t1/2) of Tepotinib
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z. Lambda z is the terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
Part A, B and C: Apparent Total Body Clearance of Tepotinib From Plasma Following Oral Administration (CL/f)
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
Part A, B and C: Apparent Volume of Distribution of Tepotinib During the Terminal Phase Following Extravascular Administration (Vz/f)
Vz/f was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) is influenced by the fraction absorbed and was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/f after oral dose is influenced by the fraction absorbed.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both serious TEAEs and non-serious TEAEs.
Measured: Time from date of informed consent signature up to end of study (assessed up to 7 weeks)
Number of Participants With Clinically Significant Abnormalities in Laboratory Values
The laboratory measurements included hematology, blood chemistry and urinalysis. Number of participants with clinically significant abnormalities in laboratory values were reported. Clinically Significance was decided by investigator.
Measured: Time from date of informed consent signature up to end of study (assessed up to 7 weeks)
Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) Findings
The 12-lead ECG recordings were obtained after 5 minutes of rest in a semi-supine position. ECG recordings included rhythm, ventricular rate, PR interval, QRS duration, QT and QTc intervals. Number of participants with clinically significant abnormalities in 12-lead ECG findings were reported. Clinically significance was decided by investigator.
Measured: Time from date of informed consent signature up to end of study (assessed up to 7 weeks)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Vital sign assessment included blood pressure, pulse rate and body temperature. Number of participants with clinically significant abnormalities in vital signs were reported. Clinically significance was decided by investigator.
Measured: Time from date of informed consent signature up to end of study (assessed up to 7 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 201825 Jan 2019

First posted14 Aug 2018
Study start23 Aug 2018
Primary completion25 Jan 2019
Study completion25 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03629223
Sponsor's protocol ID: MS200095_0044
Other IDs: 2017-005056-29, 2017
Status last verified: Oct 2023
First submitted: 9 Aug 2018
Last updated: 10 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, Open-label, 3-Parts Study With Crossover Design in Each Part to Investigate the Bioequivalence of the Tablet Formulation of TF3 Compared to TF2 (Part A), and to Investigate the Influence of Food on the PK of Each TF2 (Part B) and TF3 (Part C) of Tepotinib in Healthy Subjects
ClinicalTrials.gov ID: NCT03629223
Acronym / sponsor ID: MS200095_0044
Conditions: Healthy
Keywords: Tepotinib, Pharmacokinetics, Bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Study start: 23 Aug 2018 (actual)
Primary completion: 25 Jan 2019 (actual)
Study completion: 25 Jan 2019 (actual)
First posted: 14 Aug 2018 (actual)
Results: Posted 10 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Part A: First Tepotinib TF2 then TF3	Experimental	Drug: Tepotinib TF2, Drug: Tepotinib TF3Participants received a single oral dose of 500 milligrams (mg) Tepotinib tablet formulation 2 (TF2, reference treatment) on Day 1 of treatment period 1 followed by a single oral dose of 500 mg (2 x 250 mg) Tepotinib tablet formulation 3 (TF3, test treatment) on Day 1 of treatment period 2 under fasting conditions. The washout period was 21 days between Day 1 of each period.
Part A: First Tepotinib TF3 then TF2	Experimental	Drug: Tepotinib TF2, Drug: Tepotinib TF3Participants received a single oral dose of 500 mg (2 x 250 mg) Tepotinib TF3 (test treatment) on Day 1 of treatment period 1 followed by a single oral dose of 500 mg Tepotinib TF2 (reference treatment) on Day 1 of treatment period 2 under fasting conditions. The washout period was 21 days between Day 1 of each period.
Part B: First Tepotinib TF2 Fasted then TF2 Fed	Experimental	Drug: Tepotinib TF2Participants received a single oral dose of 500 mg Tepotinib TF2 (reference treatment) on Day 1 of treatment period 1 under fasting conditions followed by a single oral dose of 500 mg Tepotinib TF2 (reference treatment) on Day 1 of treatment period 2 under fed conditions. The washout period was 21 days between Day 1 of each period.
Part B: First Tepotinib TF2 Fed then TF2 Fasted	Experimental	Drug: Tepotinib TF2Participants received a single oral dose of 500 mg Tepotinib TF2 (reference treatment) on Day 1 of treatment period 1 under fed conditions followed by a single oral dose of 500 mg Tepotinib TF2 (reference treatment) on Day 1 of treatment period 2 under fasting conditions. The washout period was 21 days between Day 1 of each period.
Part C: First Tepotinib TF3 Fasted then TF3 Fed	Experimental	Drug: Tepotinib TF3Participants received a single oral dose of 500 mg (2 x 250 mg) Tepotinib TF3 (test treatment) on Day 1 of treatment period 1 under fasting conditions followed by a single oral dose of 500 mg (2 x 250 mg) Tepotinib TF3 (test treatment) on Day 1 of treatment period 2 under fed conditions. The washout period was 21 days between Day 1 of each period.
Part C: First Tepotinib TF3 Fed then TF3 Fasted	Experimental	Drug: Tepotinib TF3Participants received a single oral dose of 500 mg (2 x 250 mg) Tepotinib TF3 (test treatment) on Day 1 of treatment period 1 under fed conditions followed by a single oral dose of 500 mg (2 x 250 mg) Tepotinib TF3 (test treatment) on Day 1 of treatment period 2 under fasting conditions. The washout period was 21 days between Day 1 of each period.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tepotinib TF2Participants received a single oral dose of 500 mg Tepotinib TF2 under fasting or fed conditions in treatment period 1 or 2.	Drug	Part A: First Tepotinib TF2 then TF3, Part A: First Tepotinib TF3 then TF2, Part B: First Tepotinib TF2 Fasted then TF2 Fed, Part B: First Tepotinib TF2 Fed then TF2 Fasted
Tepotinib TF3Participants received single oral dose of 500 mg (2 x 250 mg)Tepotinib TF3 under fasting or fed conditions in treatment period 1 or 2.	Drug	Part A: First Tepotinib TF2 then TF3, Part A: First Tepotinib TF3 then TF2, Part C: First Tepotinib TF3 Fasted then TF3 Fed, Part C: First Tepotinib TF3 Fed then TF3 Fasted

Primary outcome

Part A, B and C: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC 0-t) of Tepotinib
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Part A, B and C: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Tepotinib
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ lambda z, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and lambda z is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Part A, B and C: Maximum Observed Plasma Concentration (Cmax) of Tepotinib
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
Cmax was obtained directly from the concentration versus time curve.

8 secondary outcomes

Part A, B and C: Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
Part A, B and C: Terminal Half-Life (t1/2) of Tepotinib
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
Part A, B and C: Apparent Total Body Clearance of Tepotinib From Plasma Following Oral Administration (CL/f)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
Part A, B and C: Apparent Volume of Distribution of Tepotinib During the Terminal Phase Following Extravascular Administration (Vz/f)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Time from date of informed consent signature up to end of study (assessed up to 7 weeks)
Number of Participants With Clinically Significant Abnormalities in Laboratory Values
Time frame: Time from date of informed consent signature up to end of study (assessed up to 7 weeks)
Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) Findings
Time frame: Time from date of informed consent signature up to end of study (assessed up to 7 weeks)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Time from date of informed consent signature up to end of study (assessed up to 7 weeks)

Results and safety

Results posted to the registry on 10 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: First Tepotinib TF2 Then TF3	20	20
Part A: First Tepotinib TF3 Then TF2	20	18
Part B: First Tepotinib TF2 Fasted Then TF2 Fed	6	6
Part B: First Tepotinib TF2 Fed Then TF2 Fasted	8	6
Part C: First Tepotinib TF3 Fasted Then TF3 Fed	6	6
Part C: First Tepotinib TF3 Fed Then TF3 Fasted	6	6

Primary outcome: Part A, B and C: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC 0-t) of Tepotinib

Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hour per milliliter (ng*h/mL)

Measure	Part A: TF2, Fasted n = 38	Part A: TF3, Fasted n = 38	Part B: TF2, Fasted n = 12	Part B: TF2, Fed n = 14	Part C: TF3, Fasted n = 12	Part C: TF3, Fed n = 12
Value	16146 (23.4)	18645 (21.0)	12609 (38.1)	23457 (25.1)	17964 (19.8)	29307 (25.0)

Part A: TF2, Fasted vs Part A: TF3, Fasted: Percentage of Ratio of Geometric LS-Mean: 115.35 (90% CI 108.55 to 122.58)
Part B: TF2, Fasted vs Part B: TF2, Fed: Percentage of ratio of Geometric LS-Mean: 186.37 (90% CI 163.61 to 212.28)
Part C: TF3, Fasted vs Part C: TF3, Fed: Percentage of ratio of Geometric LS-Mean: 163.15 (90% CI 146.17 to 182.10)

Population analysed: Pharmacokinetic.(PK) Analysis Set included participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect comparability of PK results, with adequate trial medication compliance, who had valid primary endpoints for both treatments for Part A; and who had at least 3 post-dose concentration measurements for Part B; C.

Primary outcome: Part A, B and C: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Tepotinib

Measure	Part A: TF2, Fasted n = 38	Part A: TF3, Fasted n = 38	Part B: TF2, Fasted n = 12	Part B: TF2, Fed n = 14	Part C: TF3, Fasted n = 12	Part C: TF3, Fed n = 12
Value	16728 (23.9)	19316 (21.3)	13037 (38.2)	24443 (25.9)	18447 (20.0)	30118 (25.5)

Part A: TF2, Fasted vs Part A: TF3, Fasted: Percentage of ratio of Geometric LS-Mean: 115.34 (90% CI 108.51 to 122.60)
Part B: TF2, Fasted vs Part B: TF2, Fed: Percentage of ratio of Geometric LS-Mean: 186.67 (90% CI 163.78 to 212.77)
Part C: TF3, Fasted vs Part C: TF3, Fed: Percentage of ratio of Geometric LS-Mean: 163.26 (90% CI 146.09 to 182.46)

Population analysed: PK Analysis Set included participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect comparability of PK results, with adequate trial medication compliance, who had valid primary endpoints for both treatments for Part A; and who had at least 3 post-dose concentration measurements for Part B; C.

Primary outcome: Part A, B and C: Maximum Observed Plasma Concentration (Cmax) of Tepotinib

Measure	Part A: TF2, Fasted n = 38	Part A: TF3, Fasted n = 38	Part B: TF2, Fasted n = 12	Part B: TF2, Fed n = 14	Part C: TF3, Fasted n = 12	Part C: TF3, Fed n = 12
Value	253 (20.6)	288 (22.5)	199 (29.5)	476 (19.6)	280 (15.3)	559 (17.0)

Part A: TF2, Fasted vs Part A: TF3, Fasted: Percentage of ratio of Geometric LS-Mean: 113.57 (90% CI 107.62 to 119.85)
Part B: TF2, Fasted vs Part B: TF2, Fed: Percentage of ratio of Geometric LS-Mean: 236.51 (90% CI 215.69 to 259.34)
Part C: TF3, Fasted vs Part C: TF3, Fed: Percentage of ratio of Geometric LS-Mean: 199.61 (90% CI 176.44 to 225.82)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Time from date of informed consent signature up to end of study (assessed up to 7 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: TF2, Fasted	0 of 38 (0%)	18 of 38 (47.4%)	0 of 38
Part A: TF3, Fasted	0 of 40 (0%)	14 of 40 (35%)	0 of 40
Part B: TF2, Fasted	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Part B: TF2, Fed	1 of 14 (7.1%)	9 of 14 (64.3%)	0 of 14
Part C: TF3, Fasted	0 of 12 (0%)	6 of 12 (50%)	0 of 12
Part C: TF3, Fed	0 of 12 (0%)	6 of 12 (50%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Trial Awareness and Transparency websiteLink provided by the sponsor.
Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
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)Link provided by the sponsor.

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Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Responsible study director

Merck KGaA, Darmstadt, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tepotinib TF2 and Tepotinib TF3 in people with Healthy, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A, B and C: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC 0-t) of Tepotinib (time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours post-dose on Day 1 of each treatment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03629223.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.