NCT05213481 is a Phase 1 clinical trial of Tepotinib in Healthy, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.

What drugs are being tested in NCT05213481?

Interventions in NCT05213481: Tepotinib, Carbamazepine.

Is NCT05213481 still recruiting?

NCT05213481 is currently completed. Last updated 8 March 2024.

Are results published for NCT05213481?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-03-08 · How we verify

NCT05213481

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Tepotinib Drug-Drug Interaction Study With Carbamazepine in Healthy Participants

Completed Phase 1 Results posted Last updated 8 March 2024

What this trial tests

Phase 1 trial testing Tepotinib in Healthy in 18 participants. Completed in 6 May 2022.

Timeline

15 December 2021

Primary endpoint
6 May 2022

6 May 2022

Quick facts

Lead sponsor	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	15 December 2021
Primary completion	6 May 2022
Estimated completion	6 May 2022
Sites	1 location across Germany

Drugs / interventions tested

Tepotinib — full drug profile →
Carbamazepine (carbamazepine) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tepotinib Primary · Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose

The AUC from time zero (= dosing time) extrapolated to infinity, based on the predicted value for the concentration at tlast, as estimated using the linear regression from lambda (λ)z determination.

Group	Value	95% CI
Tepotinib	25101	± 20.2
Tepotinib Then Carbamazepine	16738	± 14.1

Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of Tepotinib Primary · Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose

The AUC from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. Calculated using the mixed log-linear trapezoidal rule (linear up, log down).

Group	Value	95% CI
Tepotinib	24069	± 20.2
Tepotinib Then Carbamazepine	16272	± 13.4

Maximum Observed Plasma Concentration (Cmax) of Tepotinib Primary · Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose

Cmax was obtained directly from the concentration versus time curve.

Group	Value	95% CI
Tepotinib	414	± 15.4
Tepotinib Then Carbamazepine	372	± 18.2

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAES With Severity of Grade Greater or Equal to 3 Secondary · Baseline (Day 1) up to 10 Weeks

An adverse event (AE) was defined as any untoward medical occurrence in a participant. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study intervention. A serious adverse event (SAE) was any untoward medical occurrence 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. TEAE's were those events with ons

Any TEAE

Group	Value	95% CI
Tepotinib Then Carbamazepine	17

Any serious TEAE

Group	Value	95% CI
Tepotinib Then Carbamazepine	0

Any TEAE of Grade ≥ 3 (severe)

Group	Value	95% CI
Tepotinib Then Carbamazepine	0

Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values Secondary · Baseline (Day 1) up to 10 Weeks

Number of participants with clinically significant change from baseline in laboratory parameters were reported. Clinical Significance was decided by the investigator. Laboratory investigation included hematology, biochemistry, urinalysis, and coagulation.

Hematology

Group	Value	95% CI
Tepotinib Then Carbamazepine	0

Biochemistry

Group	Value	95% CI
Tepotinib Then Carbamazepine	0

Urinalysis

Group	Value	95% CI
Tepotinib Then Carbamazepine	0

Coagulation

Group	Value	95% CI
Tepotinib Then Carbamazepine	0

Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG) Secondary · Baseline (Day 1) up to 10 Weeks

Number of participants with clinically significant change from baseline in ECG parameters were reported. Clinical Significance was decided by the investigator. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Respiratory Rate, Pulse Rate, QRS, QT and QTcB calculated by the Bazett formula.

Group	Value	95% CI
Tepotinib Then Carbamazepine	0

Number of Participants With Clinically Meaningful Change From Baseline in Vital Signs Secondary · Baseline (Day 1) up to 10 Weeks

Number of participants with clinically significant change from baseline in vital signs. Clinical Significance was decided by the investigator. Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate.

Group	Value	95% CI
Tepotinib Then Carbamazepine	0

Total Body Clearance of Drug From Plasma (CL/f) for Tepotinib Secondary · Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose

CL/f following oral administration was calculated as Dose/AUC0-inf, where AUC0-inf calculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clastcalc/λz, where Clastcalc was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLOQ and λz was the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve.

Group	Value	95% CI
Tepotinib	17.9	± 20.2
Tepotinib Then Carbamazepine	26.9	± 14.1

Apparent Volume of Distribution (Vz/f) for Tepotinib Secondary · Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose

Vz/F was defined as the apparent volume of distribution during the terminal phase following extravascular administration.

Group	Value	95% CI
Tepotinib	801	± 24.3
Tepotinib Then Carbamazepine	1157	± 21.2

Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib Secondary · Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose

The time to reach the maximum observed plasma concentration (Tmax) was obtained directly from the concentration versus time curve.

Group	Value	95% CI
Tepotinib	8.02	3.0 – 16.0
Tepotinib Then Carbamazepine	8.0	6.0 – 16.0

Apparent Terminal Half-Life (t1/2) of Tepotinib in Plasma Secondary · Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose

t1/2 was defined as the time taken for the plasma concentration or the amount of drug in the body to be reduced by half.

Group	Value	95% CI
Tepotinib	31.0	± 19.4
Tepotinib Then Carbamazepine	29.8	± 25.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline (Day 1) up to 10 Weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tepotinib

Serious: 0/18 (0%)

Deaths: 0/18

Carbamazepine

Serious: 0/14 (0%)

Deaths: 0/14

Tepotinib Then Carbamazepine

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (38 terms — click to expand)

Reaction	System	Tepotinib	Carbamazepine	Tepotinib Then Carbamazepine
Somnolence	Nervous system disorders	—	—	—
Feeling drunk	General disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Fatigue	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
COVID-19	Infections and infestations	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—
Hypersomnia	Nervous system disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Hot flush	Vascular disorders	—	—	—
Diplopia	Eye disorders	—	—	—
Vision blurred	Eye disorders	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—
Abnormal faeces	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Feeling hot	General disorders	—	—	—
Peripheral swelling	General disorders	—	—	—
Thirst	General disorders	—	—	—
Oral herpes	Infections and infestations	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Hypochloraemia	Metabolism and nutrition disorders	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—
Increased appetite	Metabolism and nutrition disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Muscle hypertrophy	Musculoskeletal and connective tissue disorders	—	—	—
Dysarthria	Nervous system disorders	—	—	—
Muscle contractions involuntary	Nervous system disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Restlessness	Psychiatric disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Head discomfort	Nervous system disorders	—	—	—

Data from ClinicalTrials.gov NCT05213481 adverse events section.

Sponsor's own description

The purpose of this study was to assess the effect of multiple doses of carbamazepine on single- dose tepotinib pharmacokinetics in healthy participants. Study details include: Study Duration: up to about 10 weeks; Treatment Duration: single dose of tepotinib on Days 1 and 26, 25 days of treatment with carbamazepine (Days 8 to 32); Visit Frequency: residence in the Clinical Research Unit from Days -1 to 4 and Days 25 to 29, ambulatory daily visits from Days 5 to 24 and 30 to 33, and one ambulatory visit on Day 39.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Sensitivity of Tepotinib to Inhibitors or Inducers of CYP3A4 and P-Gp: Drug Interaction Studies and Physiologically-Based Pharmacokinetic Analysis.
Strotmann R, Lüpfert C, Krebs-Brown A, Ke A, et al · · 2025 · PMID 40679917 · DOI 10.1111/cts.70273

Verify or expand the search:

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Trials testing the same drug.

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Other Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05213481 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Last refreshed: 8 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05213481.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing