Trial Outcomes & Findings for Relative Bioavailability of Two Tepotinib Film-Coated Tablet Formulations in Healthy Volunteers (NCT NCT03021642)
NCT ID: NCT03021642
Last Updated: 2022-08-24
Results Overview
AUC0-t was calculated according to the mixed log linear trapezoidal rule.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2
Results posted on
2022-08-24
Participant Flow
Overall, 65 subjects were screened for this study. Of which, 24 subjects were randomized into the study.
Participant milestones
| Measure |
First Tepotinib Test, Then Tepotinib Reference
Subjects received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 milligram \[mg\]) in Treatment period 1 (Day 1) followed by a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in Treatment period 2 (Day 22). A washout period of 21 days was maintained between the 2 treatment periods.
|
First Tepotinib Reference, Then Tepotinib Test
Subjects received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in Treatment period 1 (Day 1) followed by a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg) in Treatment period 2 (Day 22). A washout period of 21 days was maintained between the 2 treatment periods.
|
|---|---|---|
|
Treatment Period 1 (Day 1)
STARTED
|
12
|
12
|
|
Treatment Period 1 (Day 1)
COMPLETED
|
12
|
12
|
|
Treatment Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (21 Days)
STARTED
|
12
|
12
|
|
Washout Period (21 Days)
COMPLETED
|
11
|
11
|
|
Washout Period (21 Days)
NOT COMPLETED
|
1
|
1
|
|
Treatment Period 2 (Day 22)
STARTED
|
11
|
11
|
|
Treatment Period 2 (Day 22)
COMPLETED
|
11
|
11
|
|
Treatment Period 2 (Day 22)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
First Tepotinib Test, Then Tepotinib Reference
Subjects received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 milligram \[mg\]) in Treatment period 1 (Day 1) followed by a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in Treatment period 2 (Day 22). A washout period of 21 days was maintained between the 2 treatment periods.
|
First Tepotinib Reference, Then Tepotinib Test
Subjects received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in Treatment period 1 (Day 1) followed by a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg) in Treatment period 2 (Day 22). A washout period of 21 days was maintained between the 2 treatment periods.
|
|---|---|---|
|
Washout Period (21 Days)
Adverse Event
|
1
|
1
|
Baseline Characteristics
Relative Bioavailability of Two Tepotinib Film-Coated Tablet Formulations in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=24 Participants
All subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg) or a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment Period 1 or 2.
|
|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 10.03 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The pharmacokinetic (PK) analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.
AUC0-t was calculated according to the mixed log linear trapezoidal rule.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=23 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=23 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) at Concentration at or Above Lower Limit of Quantitation (LLOQ) of Tepotinib
|
25159.2 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 27.0
|
25983.7 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 24.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.
AUC0-inf was 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
| Measure |
Tepotinib Test Treatment
n=18 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=17 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tepotinib
|
25709.6 ng*h/mL
Geometric Coefficient of Variation 29.6
|
26990.3 ng*h/mL
Geometric Coefficient of Variation 26.1
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.
Cmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=23 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=23 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Maximum Plasma Concentration Observed (Cmax) of Tepotinib
|
463.0 ng/mL
Geometric Coefficient of Variation 26.2
|
486.3 ng/mL
Geometric Coefficient of Variation 19.8
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=23 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=23 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib
|
8.000 hours
Interval 4.0 to 24.0
|
8.000 hours
Interval 4.0 to 16.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.
AUC0-t at which the concentration was at or above LLOQ was calculated according to the mixed log linear trapezoidal rule.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=23 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=23 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) of Tepotinib Metabolites (MSC2571109A and MSC2571107A)
MSC2571109A
|
13637.3 ng*h/mL
Geometric Coefficient of Variation 30.4
|
14164.7 ng*h/mL
Geometric Coefficient of Variation 27.1
|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) of Tepotinib Metabolites (MSC2571109A and MSC2571107A)
MSC2571107A
|
846.2 ng*h/mL
Geometric Coefficient of Variation 42.4
|
849.5 ng*h/mL
Geometric Coefficient of Variation 36.3
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure and "Number Analyzed" signifies those subjects who were evaluable for specified category.
AUC0-inf was 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
| Measure |
Tepotinib Test Treatment
n=21 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=22 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tepotinib Metabolites (MSC2571109A and MSC2571107A)
MSC2571107A
|
865.0 ng*h/mL
Geometric Coefficient of Variation 39.7
|
830.4 ng*h/mL
Geometric Coefficient of Variation 35.6
|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tepotinib Metabolites (MSC2571109A and MSC2571107A)
MSC2571109A
|
13932.6 ng*h/mL
Geometric Coefficient of Variation 31.0
|
14541.7 ng*h/mL
Geometric Coefficient of Variation 25.5
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.
Cmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=23 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=23 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Maximum Plasma Concentration Observed (Cmax) of Tepotinib Metabolites (MSC2571109A and MSC2571107A)
MSC2571109A
|
160.40 ng/mL
Geometric Coefficient of Variation 28.6
|
160.86 ng/mL
Geometric Coefficient of Variation 24.4
|
|
Maximum Plasma Concentration Observed (Cmax) of Tepotinib Metabolites (MSC2571109A and MSC2571107A)
MSC2571107A
|
11.630 ng/mL
Geometric Coefficient of Variation 38.2
|
11.299 ng/mL
Geometric Coefficient of Variation 29.9
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.
Tmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=23 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=23 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib Metabolites (MSC2571109A and MSC2571107A)
MSC2571109A
|
24.00 hours
Interval 24.0 to 48.0
|
24.02 hours
Interval 24.0 to 97.3
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib Metabolites (MSC2571109A and MSC2571107A)
MSC2571107A
|
24.00 hours
Interval 16.0 to 48.0
|
24.00 hours
Interval 16.0 to 48.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure and "Number Analyzed" signifies those subjects who were evaluable for specified category.
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
| Measure |
Tepotinib Test Treatment
n=21 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=22 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Apparent Terminal Half-Life (t1/2) of Tepotinib and Metabolites (MSC2571109A and MSC2571107A) in Plasma
Tepotinib
|
35.27 hours
Geometric Coefficient of Variation 18.1
|
34.27 hours
Geometric Coefficient of Variation 22.5
|
|
Apparent Terminal Half-Life (t1/2) of Tepotinib and Metabolites (MSC2571109A and MSC2571107A) in Plasma
MSC2571109A
|
47.33 hours
Geometric Coefficient of Variation 25.4
|
46.39 hours
Geometric Coefficient of Variation 28.8
|
|
Apparent Terminal Half-Life (t1/2) of Tepotinib and Metabolites (MSC2571109A and MSC2571107A) in Plasma
MSC2571107A
|
42.39 hours
Geometric Coefficient of Variation 17.0
|
40.18 hours
Geometric Coefficient of Variation 21.3
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure and "Number Analyzed" signifies those subjects who were evaluable for specified category.
Apparent terminal rate constant was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=21 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=22 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Apparent Terminal Rate Constant (λz) of Tepotinib and Metabolites (MSC2571109A and MSC2571107A) in Plasma
Tepotinib
|
0.019652 1/h
Geometric Coefficient of Variation 18.1
|
0.020229 1/h
Geometric Coefficient of Variation 22.5
|
|
Apparent Terminal Rate Constant (λz) of Tepotinib and Metabolites (MSC2571109A and MSC2571107A) in Plasma
MSC2571109A
|
0.014643 1/h
Geometric Coefficient of Variation 25.4
|
0.014942 1/h
Geometric Coefficient of Variation 28.8
|
|
Apparent Terminal Rate Constant (λz) of Tepotinib and Metabolites (MSC2571109A and MSC2571107A) in Plasma
MSC2571107A
|
0.016350 1/h
Geometric Coefficient of Variation 17.0
|
0.017252 1/h
Geometric Coefficient of Variation 21.3
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.
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
| Measure |
Tepotinib Test Treatment
n=18 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=17 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Total Body Clearance of Drug From Plasma (CL/f) for Tepotinib
|
17.503 liter/hour
Geometric Coefficient of Variation 29.6
|
16.673 liter/hour
Geometric Coefficient of Variation 26.1
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.
Vz/f is 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 during the terminal phase was reported.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=18 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=17 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/f) for Tepotinib
|
890.7 liters
Geometric Coefficient of Variation 27.7
|
824.2 liters
Geometric Coefficient of Variation 21.4
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure and "Number Analyzed" signifies those subjects who were evaluable for specified category.
%AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: %AUCextra = (1- \[AUC0-t / AUC0-inf\])\*100. %AUCextra was reported in terms of percentage of AUC0-inf.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=21 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=22 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Extrapolated Area Under the Plasma Concentration-Time Curve From Time t to Infinity (%AUCextra) of Tepotinib and Metabolites (MSC2571109A and MSC2571107A)
Tepotinib
|
1.5025 percentage of AUC0-inf
Geometric Coefficient of Variation 36.7
|
1.5394 percentage of AUC0-inf
Geometric Coefficient of Variation 44.7
|
|
Extrapolated Area Under the Plasma Concentration-Time Curve From Time t to Infinity (%AUCextra) of Tepotinib and Metabolites (MSC2571109A and MSC2571107A)
MSC2571109A
|
0.4040 percentage of AUC0-inf
Geometric Coefficient of Variation 45.9
|
0.4257 percentage of AUC0-inf
Geometric Coefficient of Variation 48.1
|
|
Extrapolated Area Under the Plasma Concentration-Time Curve From Time t to Infinity (%AUCextra) of Tepotinib and Metabolites (MSC2571109A and MSC2571107A)
MSC2571107A
|
0.9715 percentage of AUC0-inf
Geometric Coefficient of Variation 49.1
|
0.9748 percentage of AUC0-inf
Geometric Coefficient of Variation 46.3
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure and "Number Analyzed" signifies those subjects who were evaluable for specified category.
Ratio of AUC0-inf of Metabolite (MSC2571109A or MSC2571107A) to AUC0-inf of tepotinib was reported.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=21 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=22 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Metabolite (MSC2571109A or MSC2571107A) to AUC0-inf of Tepotinib
MSC2571109A
|
0.5362 ratio
Geometric Coefficient of Variation 16.3
|
0.5353 ratio
Geometric Coefficient of Variation 18.0
|
|
Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Metabolite (MSC2571109A or MSC2571107A) to AUC0-inf of Tepotinib
MSC2571107A
|
0.03397 ratio
Geometric Coefficient of Variation 25.9
|
0.03216 ratio
Geometric Coefficient of Variation 22.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2Population: The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.
Ratio of Cmax of metabolite (MSC2571109A or MSC2571107A) to Cmax of tepotinib was reported.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=23 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=23 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Ratio of Maximum Plasma Concentration Observed (Cmax) of Metabolite (MSC2571109A or MSC2571107A) to Cmax of Tepotinib
MSC2571109A
|
0.3464 ratio
Geometric Coefficient of Variation 22.4
|
0.3308 ratio
Geometric Coefficient of Variation 23.4
|
|
Ratio of Maximum Plasma Concentration Observed (Cmax) of Metabolite (MSC2571109A or MSC2571107A) to Cmax of Tepotinib
MSC2571107A
|
0.02512 ratio
Geometric Coefficient of Variation 29.0
|
0.02323 ratio
Geometric Coefficient of Variation 29.3
|
SECONDARY outcome
Timeframe: Baseline up to end of trial (up to Day 43)Population: SAF population. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment.Thus, number of subjects analyzed per treatment is mentioned as 23.
An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. 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. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=23 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=23 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation
TEAE leading to Discontinuation
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation
TEAEs
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation
Serious TEAEs
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation
TEAEs Leading to Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of trial (up to Day 43)Population: SAF population. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
Number of subjects with clinically significant change from baseline in vital signs, ECG and laboratory parameters were reported. Clinical Significance was decided by the investigator. Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. The 12-lead ECGs were recorded after the subjects have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), RR, PR, QRS, QT and QTcB calculated by the Bazett formula. Laboratory investigation included hematology, biochemistry, urinalysis, and coagulation.
Outcome measures
| Measure |
Tepotinib Test Treatment
n=23 Participants
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=23 Participants
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Electrocardiogram (ECG) and Laboratory Parameters
Vital Signs
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Electrocardiogram (ECG) and Laboratory Parameters
ECG Values
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Electrocardiogram (ECG) and Laboratory Parameters
Laboratory Values
|
0 Participants
|
0 Participants
|
Adverse Events
Tepotinib Test Treatment
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Tepotinib Reference Treatment
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tepotinib Test Treatment
n=23 participants at risk
Subjects who received a single oral dose of test treatment of film-coated tepotinib tablet (1\*500 mg tablet) in either Treatment period 1 or 2.
|
Tepotinib Reference Treatment
n=23 participants at risk
Subjects who received a single oral dose of reference treatment of film-coated tepotinib tablet (5\*100 mg tablet) in either Treatment period 1 or 2.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Injury, poisoning and procedural complications
Foreign Body In Eye
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Investigations
Amylase Increased
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Investigations
Lipase Increased
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
General disorders
Catheter Site Inflammation
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
General disorders
Catheter Site Related Reaction
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
8.7%
2/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
General disorders
Chills
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
8.7%
2/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
8.7%
2/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
8.7%
2/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
|
Infections and infestations
Influenza
|
4.3%
1/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
0.00%
0/23 • Baseline up to end of trial (up to Day 43)
The safety analysis set included all subjects who received at least 1 dose of the IMP and had follow up safety data. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.
|
Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publications and presentations of the results (abstracts in journals or newspapers, oral presentations, etc.), either in whole or in part, by Investigators or their representatives will require review by the Sponsor before submission. The Sponsor will not suppress publication, but maintains the right to delay publication in order to protect intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER