HealthyPhase 1NCT03492437

Effect of Tepotinib on the PK of the P-gp Substrate Dabigatran Etexilate

A Phase 1 study testing Dabigatran Etexilate and Tepotinib 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

This study investigated the effect of Tepotinib on the pharmacokinetics (PK) of the p-glycoprotein (P-gp) probe substrate Dabigatran etexilate. Read more about this study

Who is it for?: Ages 18 to 44 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Dabigatran Etexilate and Tepotinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteGermany
Study dates: 17 May 2018to 27 Aug 2018
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 44 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)
A male participant must agree to use and to have his female partner of childbearing potential to use highly effective method of contraception
Participant must have given written informed consent before any study-related activities
All values for hematology, coagulation, and biochemistry tests of blood and urinalysis are within the normal range. Minor (solitary) non-clinically relevant deviation(s) are allowed as judged by the Investigator
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 > 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
Supine systolic blood pressure (SBP) greater than (>) 140 millimeter of mercury (mmHg) or less than (<) 90 mmHg, diastolic blood pressure (DBP) > 90 or < 50 mmHg, and pulse rate > 90 or <50 beats per minute (bpm) at Screening and at admission on Day-1.
12-Lead electrocardiograms (ECG) showing a corrected QT interval per Fridericia's formula (QTcF) > 450 milliseconds (ms), PR > 215 ms, or QRS > 120 ms (at Screening)
Creatinine clearance estimated glomerular filtration rate (eGFR) < 90 milliliter per minute (mL/min) (at Screening)

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Participants with gall bladder removal or other relevant surgery of gastrointestinal tract
History of any malignancy
History of epilepsy
Ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or excipients
Participants who in the Investigator's judgment were perceived as having an increased risk of bleeding
Positive screen for alcohol or drugs of abuse (at Screening and Day -1)
Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), and human immunodeficiency virus 1 and 2 antibodies (HIV1/HIV2 antibodies) (at Screening)
Excessive consumption of xanthine-containing food or beverages before study drug administration until collection of last pharmacokinetic (PK) sample in each period (at Screening and Day -1)
Receipt of any prescription or nonprescription medication within 14 days or 5 half-lives, before study drug administration
Smoker or former smoker who stopped smoking less than 6 months before the time of the Screening Visit
Intake of grapefruit, Seville orange, cranberry or juices of these 3 fruits, or St. John's Wort, from 14 days prior to Day -1
Inability to communicate or cooperate with the Investigator
Other factors, which in the opinion of the Investigator may interfere with study conduct (at Screening and Day -1 of first Period only)
Legal incapacity or limited legal capacity
Participants kept in detention
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 I, Open-label, Single Sequence, Two-Period Study to Evaluate the Effect of Tepotinib on P-gp by Investigating the PK of the P-gp Probe Substrate Dabigatran Etexilate in Healthy Subjects

This study investigated the effect of Tepotinib on the pharmacokinetics (PK) of the p-glycoprotein (P-gp) probe substrate Dabigatran etexilate.

Conditions: Healthy
Being tested: Dabigatran Etexilate, Tepotinib
Keywords: Non-small cell lung cancer (NSCLC), P-glycoprotein, Tepotinib, Dabigatran Etexilate
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

Dabigatran EtexilateDrug
Participants received single oral dose of Dabigatran etexilate on Day 1 of Treatment period 1 and co-administration of Dabigatran with Tepotinib on Day 8 of Treatment period 2.
TepotinibDrug
Participants received single oral dose of Tepotinib for 8 days in Treatment period 2.

Study groups in NCT03492437
Study group	Role	What they receive
Dabigatran Etexilate	Experimental	Not described Receives: Drug: Dabigatran Etexilate
Tepotinib + Dabigatran	Experimental	Not described Receives: Drug: Dabigatran Etexilate; Drug: Tepotinib

What is being measured

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

Area Under Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Total Dabigatran
AUC0-t was 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, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total Dabigatran
AUC0-inf was calculated as AUC0-t plus (+) AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clastpred/Lambda z, where Clastpred is the predicted plasma concentration at the last sampling time point, calculated from the log-linear regression line for Lambda z determination at which the measured plasma concentration is at or above Lower limit of quantification (LLOQ).
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Maximum Observed Plasma Concentration (Cmax) of Total Dabigatran
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, 24, 48 and 72 hours Post-dose on Day 1 and Day 8

Secondary outcomes (9)

Time to Reach Maximum Plasma Concentration (Tmax) of Total Dabigatran
Tmax is time to reach maximum observed plasma concentration 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, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Elimination Half Life (t1/2) of Total Dabigatran
Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Apparent Clearance (CL/f) of Total Dabigatran
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Apparent Volume of Distribution During Terminal Phase (Vz/f) of Total Dabigatran
Volume of distribution 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 was influenced by the fraction absorbed.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Percentage of Area Under the Plasma Concentration-Time Curve From Time Tlast Extrapolated to Infinity (AUC0-inf) Obtained by Extrapolation (AUCextra%) of Total Dabigatran
The AUC from time tlast extrapolated to infinity given as percentage of AUC0-inf. AUCextra% = (AUCextra /AUC0-inf)*100.
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Adverse event (AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event (SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs.
Measured: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2
Number of Participants With Clinically Significant Changes in Laboratory Values
Number of participants with clinically significant change in laboratory values were reported. Clinical significance was decided by the investigator. Laboratory investigation included hematology, biochemistry, virology, drugs of abuse, hormones, urinalysis, and coagulation.
Measured: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Findings
Number of participants with clinically significant change in 12-lead ECG were reported. Clinical significance was decided by the investigator. The 12-lead ECGs were recorded after the participant have rested for at least 5 minutes in supine position.
Measured: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2
Number of Participants With Clinically Significant Changes in Vital Signs
Number of participants with clinically significant change in vital signs were reported. Clinical significance was decided by the investigator. Vital signs included body temperature, blood pressure, and pulse rate.
Measured: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2

Timeline

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

17 May 201827 Aug 2018

First posted10 Apr 2018
Study start17 May 2018
Primary completion27 Aug 2018
Study completion27 Aug 2018

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.
Publications (1)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03492437
Sponsor's protocol ID: MS200095_0032
Other IDs: 2017-004074-34, 2017
Status last verified: Aug 2023
First submitted: 3 Apr 2018
Last updated: 7 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Yalkinoglu O, Becker A, Krebs-Brown A, Vetter C, Lupfert C, Perrin D, Heuer J, Biedert H, Hirt S, Bytyqi A, Bachmann A, Strotmann R. Assessment of the potential of the MET inhibitor tepotinib to affect the pharmacokinetics of CYP3A4 and P-gp substrates. Invest New Drugs. 2023 Aug;41(4):596-605. doi: 10.1007/s10637-023-01378-z. Epub 2023 Jul 6.
PubMed 37415001

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 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Open-label, Single Sequence, Two-Period Study to Evaluate the Effect of Tepotinib on P-gp by Investigating the PK of the P-gp Probe Substrate Dabigatran Etexilate in Healthy Subjects
ClinicalTrials.gov ID: NCT03492437
Acronym / sponsor ID: MS200095_0032
Conditions: Healthy
Keywords: Non-small cell lung cancer (NSCLC), P-glycoprotein, Tepotinib, Dabigatran Etexilate
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Study start: 17 May 2018 (actual)
Primary completion: 27 Aug 2018 (actual)
Study completion: 27 Aug 2018 (actual)
First posted: 10 Apr 2018 (actual)
Results: Posted 7 Aug 2023

Clinical summary

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

This study investigated the effect of Tepotinib on the pharmacokinetics (PK) of the p-glycoprotein (P-gp) probe substrate Dabigatran etexilate.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dabigatran Etexilate	Experimental	Drug: Dabigatran Etexilate
Tepotinib + Dabigatran	Experimental	Drug: Dabigatran Etexilate, Drug: Tepotinib

Who may qualify

Ages: 18 to 44 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 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)
A male participant must agree to use and to have his female partner of childbearing potential to use highly effective method of contraception
Participant must have given written informed consent before any study-related activities

Key exclusion criteria (22 listed)

Participation in a clinical study within 60 days prior to first drug administration
Whole blood donation or loss of > 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
Supine systolic blood pressure (SBP) greater than (>) 140 millimeter of mercury (mmHg) or less than (<) 90 mmHg, diastolic blood pressure (DBP) > 90 or < 50 mmHg, and pulse rate > 90 or <50 beats per minute (bpm) at Screening and at admission on Day-1.
12-Lead electrocardiograms (ECG) showing a corrected QT interval per Fridericia's formula (QTcF) > 450 milliseconds (ms), PR > 215 ms, or QRS > 120 ms (at Screening)

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
Dabigatran EtexilateParticipants received single oral dose of Dabigatran etexilate on Day 1 of Treatment period 1 and co-administration of Dabigatran with Tepotinib on Day 8 of Treatment period 2.	Drug	Dabigatran Etexilate, Tepotinib + Dabigatran
TepotinibParticipants received single oral dose of Tepotinib for 8 days in Treatment period 2.	Drug	Tepotinib + Dabigatran

Primary outcome

Area Under Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Total Dabigatran
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
AUC0-t was calculated according to the mixed log linear trapezoidal rule.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total Dabigatran
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
AUC0-inf was calculated as AUC0-t plus (+) AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clastpred/Lambda z, where Clastpred is the predicted plasma concentration at the last sampling time point, calculated from the log-linear regression line for Lambda z determination at which the measured plasma concentration is at or above Lower limit of quantification (LLOQ).
Maximum Observed Plasma Concentration (Cmax) of Total Dabigatran
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Cmax was obtained directly from the concentration versus time curve.

9 secondary outcomes

Time to Reach Maximum Plasma Concentration (Tmax) of Total Dabigatran
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Elimination Half Life (t1/2) of Total Dabigatran
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Apparent Clearance (CL/f) of Total Dabigatran
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Apparent Volume of Distribution During Terminal Phase (Vz/f) of Total Dabigatran
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Percentage of Area Under the Plasma Concentration-Time Curve From Time Tlast Extrapolated to Infinity (AUC0-inf) Obtained by Extrapolation (AUCextra%) of Total Dabigatran
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2
Number of Participants With Clinically Significant Changes in Laboratory Values
Time frame: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Findings
Time frame: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2

Results and safety

Results posted to the registry on 7 Aug 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
Dabigatran Etexilate	20	20
Tepotinib + Dabigatran	0	0

Primary outcome: Area Under Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Total Dabigatran

Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*h/mL)

Measure	Dabigatran Etexilate n = 20	Tepotinib + Dabigatran n = 19
Value	461 (74.9)	709 (64.6)

Dabigatran Etexilate vs Tepotinib + Dabigatran: Ratio of Geometric Least square Mean: 151.38 (90% CI 127.35 to 179.93)

Population analysed: Pharmacokinetic (PK) analysis set: all participants who completed at least 1 period without any relevant protocol violations with respect to factors affecting comparability of PK results with adequate study drug compliance and evaluable dabigatran PK data. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Primary outcome: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total Dabigatran

Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Dabigatran Etexilate n = 19	Tepotinib + Dabigatran n = 19
Value	544 (32.8)	730 (61.8)

Dabigatran Etexilate vs Tepotinib + Dabigatran: Ratio of Geometric Least square Mean: 144.70 (90% CI 122.89 to 170.39)

Population analysed: PK analysis set: all participants who completed at least 1 period without any relevant protocol violations with respect to factors affecting comparability of PK results with adequate study drug compliance and evaluable dabigatran PK data. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Total Dabigatran

Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8. Geometric mean (Geometric Coefficient of Variation). Unit: Nanogram per milliliter (ng/mL)

Measure	Dabigatran Etexilate n = 20	Tepotinib + Dabigatran n = 19
Value	54.5 (72.8)	76.9 (61.8)

Dabigatran Etexilate vs Tepotinib + Dabigatran: Ratio of Geometric Least square Mean: 138.45 (90% CI 121.59 to 157.65)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening up to Day 4 in Period 1; Day 1 up to Day 15 in Period 2. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran Etexilate	0 of 20 (0%)	4 of 20 (20%)	0 of 20
Tepotinib + Dabigatran	0 of 20 (0%)	15 of 20 (75%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37415001Yalkinoglu O, Becker A, Krebs-Brown A, Vetter C, Lupfert C, Perrin D, Heuer J, Biedert H, Hirt S, Bytyqi A, Bachmann A, Strotmann R. Assessment of the potential of the MET inhibitor tepotinib to affect the pharmacokinetics of CYP3A4 and P-gp substrates. Invest New Drugs. 2023 Aug;41(4):596-605. doi: 10.1007/s10637-023-01378-z. Epub 2023 Jul 6.
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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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 Dabigatran Etexilate and Tepotinib 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 7 inclusion and 22 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 7 Aug 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 7 Aug 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?

Area Under Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Total Dabigatran (time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8). 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 NCT03492437, which also lists 1 linked publication.

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 7 Aug 2023.