CClinicalTrials.gg
Sign In
CompletedNCT05213481Updated Mar 8, 2024Results posted

Tepotinib Drug-Drug Interaction Study With Carbamazepine in Healthy Participants

A Phase 1 interventional study of Tepotinib and Carbamazepine in Healthy, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-08.

Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy

Keywords

  • Clinical pharmacology
  • Metabolite
  • Induction of metabolism
03

In context

Lead sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany is the lead sponsor of 55 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Overtly healthy participants as determined by medical evaluation, including no clinically significant abnormality identified by medical history, cardiac monitoring, physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion at Screening and Day -1
  • Had a body weight within 50 and 100 kilogram (inclusive) and Body Mass Index (BMI) within the range greater than or equal (>=) 18.5 and less than or equal to (\<=) 29.9 kilogram per meter square (inclusive) at Screening
  • Male or female (not a Women of childbearing potential [WOCBP]). The Investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable. The contraception, barrier, and pregnancy testing requirements are below:
  • Contraceptive use was consistent with local regulations on contraception methods for those participating in clinical studies. Male Participants: Agree to the following during the study intervention period and for at least 1 week after the last dose of study intervention: Refrain from donating fresh and unwashed sperm PLUS (+), either: Abstain from intercourse with a WOCBP.OR Use a male condom: When having sexual intercourse with a WOCBP, who is not currently pregnant, and instruct her to use a highly effective contraceptive method with a failure rate of \< 1percent (%) per year
  • Since a condom may break or leak. Not a WOCBP, confirmed at Screening, by fulfilling at least 1 of the following criteria: Females who are postmenopausal (age-related amenorrhea >= 12 consecutive months and increased Follicle-stimulating hormone (FSH)
  • Documentation of irreversible surgical sterilization by hysterectomy, or bilateral oophorectomy, or bilateral salpingectomy
  • Other protocol defined inclusion criteria could apply

Exclusion criteria

Exclusion Criteria:

  • History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as determined by medical evaluation
  • Participants with gall bladder removal or other relevant surgery of gastrointestinal tract (appendectomy is not considered as relevant)
  • History of any malignancy except for adequately treated superficial basal cell carcinoma
  • History of epilepsy
  • Ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or excipients; history of anaphylaxis to drugs or serious allergic reactions leading to hospitalization or any other allergy reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the study
  • Any condition, including findings in the laboratory tests, medical history, or other Screening assessments, that in the opinion of the Investigator constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study's objectives, conduct, or evaluation
  • Use of any prescribed medicine or over-the-counter drug or dietary supplement, including herbal remedies, vitamins, and minerals, antacids and dietary supplements such as fish oils within 2 weeks or 5 times the half-life of the respective drug, whichever is longer, prior to the first administration of study intervention
  • Other protocol defined exclusion criteria could apply
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Tepotinib then Carbamazepine

    Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1 and Day 26 in the morning under fed state followed by Carbamazepine 100, 200 or 300mg oral dose under fed state twice daily at the same time each day in the morning and evening from Days 8 to Day 32

    Drug: Tepotinib · Drug: Carbamazepine

Interventions

  • DrugTepotinib

    Participants received Tepotinib hydrochloride hydrate film-coated tablet once daily with food on Day 1 and Day 26 in the morning.

  • DrugCarbamazepine

    Carbamazepine 100 mg twice daily at Day 8 and 9, 200 mg twice daily at Day 10 and 11, 300 mg twice daily from Day 12 to 32.

06

What researchers measure

Primary outcomes

  1. Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tepotinib

    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.

    Time frame: 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

  2. Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of Tepotinib

    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).

    Time frame: 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

  3. Maximum Observed Plasma Concentration (Cmax) of Tepotinib

    Cmax was obtained directly from the concentration versus time curve.

    Time frame: 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

Secondary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAES With Severity of Grade Greater or Equal to 3

    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 onset dates on or after the first administration of study intervention. Severity of abnormalities were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version \[24.1\]. grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE

    Time frame: Baseline (Day 1) up to 10 Weeks

  2. Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values

    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.

    Time frame: Baseline (Day 1) up to 10 Weeks

  3. Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)

    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.

    Time frame: Baseline (Day 1) up to 10 Weeks

  4. Number of Participants With Clinically Meaningful Change From Baseline in Vital Signs

    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.

    Time frame: Baseline (Day 1) up to 10 Weeks

  5. Total Body Clearance of Drug From Plasma (CL/f) for Tepotinib

    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.

    Time frame: 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

  6. Apparent Volume of Distribution (Vz/f) for Tepotinib

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

    Time frame: 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

  7. Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib

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

    Time frame: 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

  8. Apparent Terminal Half-Life (t1/2) of Tepotinib in Plasma

    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.

    Time frame: 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

07

Results

Posted Mar 8, 2024
Limitations and caveats
\[Not Specified\]

Participant flow

Participant flow — Overall Study
MilestoneTepotinib Then Carbamazepine
Started18
Completed14
Not completed4
Withdrew: Adverse event3
Withdrew: Lost to follow-up1

Outcome measures

PrimaryArea Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tepotinib

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.

Time frame:
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
Reported as:
Geometric mean · hours* nanograms per milliliter(h*ng/mL)
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tepotinib
hours* nanograms per milliliter(h*ng/mL)TepotinibTepotinib Then Carbamazepine
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tepotinib25101 ± 20.216738 ± 14.1
PrimaryArea Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of Tepotinib

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).

Time frame:
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
Reported as:
Geometric mean · h*ng/mL
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of Tepotinib
h*ng/mLTepotinibTepotinib Then Carbamazepine
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of Tepotinib24069 ± 20.216272 ± 13.4
PrimaryMaximum Observed Plasma Concentration (Cmax) of Tepotinib

Cmax was obtained directly from the concentration versus time curve.

Time frame:
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
Reported as:
Geometric mean · nanogram per mililiter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of Tepotinib
nanogram per mililiter (ng/mL)TepotinibTepotinib Then Carbamazepine
Maximum Observed Plasma Concentration (Cmax) of Tepotinib414 ± 15.4372 ± 18.2
SecondaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAES With Severity of Grade Greater or Equal to 3

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 onset dates on or after the first administration of study intervention. Severity of abnormalities were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version \[24.1\]. grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE

Time frame:
Baseline (Day 1) up to 10 Weeks
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAES With Severity of Grade Greater or Equal to 3
ParticipantsTepotinib Then Carbamazepine
Any TEAE17
Any serious TEAE0
Any TEAE of Grade ≥ 3 (severe)0
SecondaryNumber of Participants With Clinically Meaningful Change From Baseline in Laboratory Values

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.

Time frame:
Baseline (Day 1) up to 10 Weeks
Reported as:
Count of participants · Participants
Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values
ParticipantsTepotinib Then Carbamazepine
Hematology0
Biochemistry0
Urinalysis0
Coagulation0
SecondaryNumber of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)

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.

Time frame:
Baseline (Day 1) up to 10 Weeks
Reported as:
Count of participants · Participants
Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)
ParticipantsTepotinib Then Carbamazepine
Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)0
SecondaryNumber of Participants With Clinically Meaningful Change From Baseline in Vital Signs

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.

Time frame:
Baseline (Day 1) up to 10 Weeks
Reported as:
Count of participants · Participants
Number of Participants With Clinically Meaningful Change From Baseline in Vital Signs
ParticipantsTepotinib Then Carbamazepine
Number of Participants With Clinically Meaningful Change From Baseline in Vital Signs0
SecondaryTotal Body Clearance of Drug From Plasma (CL/f) for Tepotinib

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.

Time frame:
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
Reported as:
Geometric mean · liter/hour
Total Body Clearance of Drug From Plasma (CL/f) for Tepotinib
liter/hourTepotinibTepotinib Then Carbamazepine
Total Body Clearance of Drug From Plasma (CL/f) for Tepotinib17.9 ± 20.226.9 ± 14.1
SecondaryApparent Volume of Distribution (Vz/f) for Tepotinib

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

Time frame:
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
Reported as:
Geometric mean · liters
Apparent Volume of Distribution (Vz/f) for Tepotinib
litersTepotinibTepotinib Then Carbamazepine
Apparent Volume of Distribution (Vz/f) for Tepotinib801 ± 24.31157 ± 21.2
SecondaryTime to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib

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

Time frame:
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
Reported as:
Median · Hours
Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib
HoursTepotinibTepotinib Then Carbamazepine
Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib8.02 (3.0 to 16.0)8.0 (6.0 to 16.0)
SecondaryApparent Terminal Half-Life (t1/2) of Tepotinib in Plasma

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.

Time frame:
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
Reported as:
Geometric mean · Hours
Apparent Terminal Half-Life (t1/2) of Tepotinib in Plasma
HoursTepotinibTepotinib Then Carbamazepine
Apparent Terminal Half-Life (t1/2) of Tepotinib in Plasma31.0 ± 19.429.8 ± 25.8

Adverse events

Collected over Baseline (Day 1) up to 10 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tepotinib0/18 (0%)0/18 (0%)7/18 (38.9%)
Carbamazepine0/14 (0%)0/14 (0%)13/14 (92.9%)
Tepotinib Then Carbamazepine0/14 (0%)0/14 (0%)7/14 (50%)
Most frequent other events
Showing 10 of 38
Most frequent other events
EventTepotinibCarbamazepineTepotinib Then Carbamazepine
SomnolenceNervous system disorders0/186/140/14
Feeling drunkGeneral disorders0/184/140/14
DizzinessNervous system disorders0/184/140/14
FatigueGeneral disorders0/184/140/14
HeadacheNervous system disorders2/183/140/14
NauseaGastrointestinal disorders1/183/141/14
COVID-19Infections and infestations3/180/140/14
LymphadenopathyBlood and lymphatic system disorders0/182/141/14
HypersomniaNervous system disorders0/182/140/14
PruritusSkin and subcutaneous tissue disorders0/182/140/14

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Tepotinib Then Carbamazepine
Mean43 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Tepotinib Then Carbamazepine
Female5
Male13
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Tepotinib Then Carbamazepine
Hispanic or Latino2
Not Hispanic or Latino16
Unknown or Not Reported00
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Tepotinib Then Carbamazepine
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White18
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Nuvisan GmbH
    Neu-Ulm, Germany
09

References and documents

Study documents

  • Study protocol · Feb 21, 2022
  • Statistical analysis plan · Jan 11, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05213481
Lead sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Responsible party
Sponsor
First posted
Jan 28, 2022
Start date
Dec 15, 2021
Primary completion
May 6, 2022
Completion
May 6, 2022
Results posted
Mar 8, 2024
Last update
Mar 8, 2024

Study contacts

Medical Responsible
study director · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

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

Start the discussion