Trial Outcomes & Findings for Tepotinib Drug-Drug Interaction Study With Carbamazepine in Healthy Participants (NCT NCT05213481)

Last Updated: 2024-03-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

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

Results posted on

2024-03-08

Participant Flow

A total of 29 participants were screened, out of which 18 participants received the study drug.

Participant milestones

Participant milestones
Measure	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 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.
Overall Study STARTED	18
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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 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.
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	1

Baseline Characteristics

Tepotinib Drug-Drug Interaction Study With Carbamazepine in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tepotinib Then Carbamazepine n=18 Participants 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 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.
Age, Continuous	43 Years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	00 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: PK analysis set included all participants who had administered any dose of any study intervention and completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = overall number of participants evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Tepotinib n=17 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1.	Tepotinib Then Carbamazepine n=14 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tepotinib	25101 hours* nanograms per milliliter(h*ng/mL) Geometric Coefficient of Variation 20.2	16738 hours* nanograms per milliliter(h*ng/mL) Geometric Coefficient of Variation 14.1

PRIMARY outcome

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).

Outcome measures

Outcome measures
Measure	Tepotinib n=17 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1.	Tepotinib Then Carbamazepine n=14 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32.
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of Tepotinib	24069 h*ng/mL Geometric Coefficient of Variation 20.2	16272 h*ng/mL Geometric Coefficient of Variation 13.4

PRIMARY outcome

Cmax was obtained directly from the concentration versus time curve.

Outcome measures

Outcome measures
Measure	Tepotinib n=17 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1.	Tepotinib Then Carbamazepine n=14 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32.
Maximum Observed Plasma Concentration (Cmax) of Tepotinib	414 nanogram per mililiter (ng/mL) Geometric Coefficient of Variation 15.4	372 nanogram per mililiter (ng/mL) Geometric Coefficient of Variation 18.2

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 10 Weeks

Population: Safety Analysis Set included all participants, who were administered any dose of any study intervention.

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

Outcome measures

Outcome measures
Measure	Tepotinib n=18 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1.	Tepotinib Then Carbamazepine Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAES With Severity of Grade Greater or Equal to 3 Any TEAE	17 Participants	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAES With Severity of Grade Greater or Equal to 3 Any serious TEAE	0 Participants	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAES With Severity of Grade Greater or Equal to 3 Any TEAE of Grade ≥ 3 (severe)	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 10 Weeks

Population: The safety analysis set included all participants who had received any dose of the study medication.

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.

Outcome measures

Outcome measures
Measure	Tepotinib n=18 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1.	Tepotinib Then Carbamazepine Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32.
Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values Hematology	0 Participants	—
Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values Biochemistry	0 Participants	—
Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values Urinalysis	0 Participants	—
Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values Coagulation	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 10 Weeks

Population: The safety analysis set included all participants who had received any dose of the study medication.

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.

Outcome measures

Outcome measures
Measure	Tepotinib n=18 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1.	Tepotinib Then Carbamazepine Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32.
Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 10 Weeks

Population: The safety analysis set included all participants who had received any dose of the study medication.

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.

Outcome measures

Outcome measures
Measure	Tepotinib n=18 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1.	Tepotinib Then Carbamazepine Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32.
Number of Participants With Clinically Meaningful Change From Baseline in Vital Signs	0 Participants	—

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Tepotinib n=17 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1.	Tepotinib Then Carbamazepine n=14 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32.
Total Body Clearance of Drug From Plasma (CL/f) for Tepotinib	17.9 liter/hour Geometric Coefficient of Variation 20.2	26.9 liter/hour Geometric Coefficient of Variation 14.1

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Tepotinib n=17 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1.	Tepotinib Then Carbamazepine n=14 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32.
Apparent Volume of Distribution (Vz/f) for Tepotinib	801 liters Geometric Coefficient of Variation 24.3	1157 liters Geometric Coefficient of Variation 21.2

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Tepotinib n=17 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1.	Tepotinib Then Carbamazepine n=14 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32.
Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib	8.02 Hours Interval 3.0 to 16.0	8.0 Hours Interval 6.0 to 16.0

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Tepotinib n=17 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1.	Tepotinib Then Carbamazepine n=14 Participants Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32.
Apparent Terminal Half-Life (t1/2) of Tepotinib in Plasma	31.0 Hours Geometric Coefficient of Variation 19.4	29.8 Hours Geometric Coefficient of Variation 25.8

Adverse Events

Tepotinib

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Carbamazepine

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Tepotinib Then Carbamazepine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tepotinib n=18 participants at risk Participants received 500 mg of Tepotinib hydrochloride hydrate film coated tablet once daily with food on Day 1.	Carbamazepine n=14 participants at risk 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 25.	Tepotinib Then Carbamazepine n=14 participants at risk Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	14.3% 2/14 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks
General disorders Feeling drunk	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	28.6% 4/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Nervous system disorders Dizziness	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	28.6% 4/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Nervous system disorders Headache	11.1% 2/18 • Baseline (Day 1) up to 10 Weeks	21.4% 3/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Nervous system disorders Hypersomnia	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	14.3% 2/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	14.3% 2/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Vascular disorders Hot flush	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	14.3% 2/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Eye disorders Diplopia	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	14.3% 2/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Eye disorders Vision blurred	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	14.3% 2/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Gastrointestinal disorders Flatulence	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	14.3% 2/14 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks
Gastrointestinal disorders Nausea	5.6% 1/18 • Baseline (Day 1) up to 10 Weeks	21.4% 3/14 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks
General disorders Fatigue	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	28.6% 4/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 1/18 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks
Nervous system disorders Somnolence	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	42.9% 6/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Blood and lymphatic system disorders Leukopenia	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Blood and lymphatic system disorders Anaemia	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Gastrointestinal disorders Abdominal pain	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks
Gastrointestinal disorders Abdominal pain upper	5.6% 1/18 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks
Gastrointestinal disorders Abnormal faeces	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks
Gastrointestinal disorders Vomiting	5.6% 1/18 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
General disorders Feeling hot	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks
General disorders Peripheral swelling	5.6% 1/18 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
General disorders Thirst	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Infections and infestations COVID-19	16.7% 3/18 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Infections and infestations Oral herpes	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Investigations Gamma-glutamyltransferase increased	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Metabolism and nutrition disorders Decreased appetite	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Metabolism and nutrition disorders Increased appetite	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Musculoskeletal and connective tissue disorders Back pain	5.6% 1/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Musculoskeletal and connective tissue disorders Muscle hypertrophy	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks
Nervous system disorders Dysarthria	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Nervous system disorders Muscle contractions involuntary	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Psychiatric disorders Insomnia	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Psychiatric disorders Restlessness	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks
Nervous system disorders Head discomfort	0.00% 0/18 • Baseline (Day 1) up to 10 Weeks	7.1% 1/14 • Baseline (Day 1) up to 10 Weeks	0.00% 0/14 • Baseline (Day 1) up to 10 Weeks

Additional Information

Communication Center

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

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place