Trial Outcomes & Findings for Effect of Tepotinib on PK of CYP3A Substrate Midazolam (NCT NCT03628339)
NCT ID: NCT03628339
Last Updated: 2023-07-28
Results Overview
AUC0-t a Pharmacokinetic (PK) parameter was calculated according to the mixed log linear trapezoidal rule.
COMPLETED
PHASE1
12 participants
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 43 hours post-dose on Day 1 of period 1 and Day 11 of Period 2
2023-07-28
Participant Flow
Overall 25 participants were screened in this study. Out of which, 12 participants received Midazolam and Tepotinib + Midazolam treatment.
Participant milestones
| Measure |
Midazolam (Reference Treatment)
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
12
|
0
|
|
Treatment Period 1
COMPLETED
|
12
|
0
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2
STARTED
|
0
|
12
|
|
Treatment Period 2
COMPLETED
|
0
|
12
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Tepotinib on PK of CYP3A Substrate Midazolam
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
All participants who received single oral dose of 7.5 mg midazolam tablet on Day 1 of treatment period 1 and oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 7.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 43 hours post-dose on Day 1 of period 1 and Day 11 of Period 2Population: PK Analysis Set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, who have received at least one dose of midazolam and who have at least 3 post-dose concentration measurements.
AUC0-t a Pharmacokinetic (PK) parameter was calculated according to the mixed log linear trapezoidal rule.
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Area Under Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Midazolam
|
107969 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 42.0
|
109477 hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 46.5
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 43 hours post-dose on Day 1 of period 1 and Day 11 of Period 2Population: PK Analysis Set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, who have received at least one dose of midazolam and who have at least 3 post-dose concentration measurements.
AUC0-inf was calculated as AUC0-t plus (+) AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clastpred/Lambda z, where Clastpred is the predicted plasma concentration at the last sampling time point, calculated from the log-linear regression line for Lambda z determination at which the measured plasma concentration is at or above Lower limit of quantification (LLOQ).
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Midazolam
|
109285 h*pg/mL
Geometric Coefficient of Variation 41.9
|
110550 h*pg/mL
Geometric Coefficient of Variation 46.2
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 43 hours post-dose on Day 1 of period 1 and Day 11 of Period 2Population: PK Analysis Set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, who have received at least one dose of midazolam and who have at least 3 post-dose concentration measurements.
Cmax was obtained directly from concentration versus time curve.
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Midazolam
|
49172 pg/mL
Geometric Coefficient of Variation 59.7
|
50954 pg/mL
Geometric Coefficient of Variation 54.1
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 43 hours post-dose on Day 1 of period 1 and Day 11 of Period 2Population: PK Analysis Set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, who have received at least one dose of midazolam and who have at least 3 post-dose concentration measurements.
Tmax is time to reach maximum observed plasma concentration obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Midazolam and Midazolam Metabolite (1-Hydroxymidazolam)
Midazolam
|
0.500 Hours
Interval 0.5 to 1.5
|
0.508 Hours
Interval 0.483 to 2.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Midazolam and Midazolam Metabolite (1-Hydroxymidazolam)
Midazolam Metabolite (1- Hydroxymidazolam)
|
0.500 Hours
Interval 0.5 to 2.0
|
0.508 Hours
Interval 0.483 to 2.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 43 hours post-dose on Day 1 of period 1 and Day 11 of Period 2Population: PK Analysis Set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, who have received at least one dose of midazolam and who have at least 3 post-dose concentration measurements.
Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Elimination Half Life (t1/2) of Midazolam and Midazolam Metabolite (1-Hydroxymidazolam)
Midazolam
|
5.52 Hours
Geometric Coefficient of Variation 31.4
|
4.81 Hours
Geometric Coefficient of Variation 41.2
|
|
Elimination Half Life (t1/2) of Midazolam and Midazolam Metabolite (1-Hydroxymidazolam)
Midazolam Metabolite (1- Hydroxymidazolam)
|
6.34 Hours
Geometric Coefficient of Variation 29.8
|
6.90 Hours
Geometric Coefficient of Variation 26.8
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 43 hours post-dose on Day 1 of period 1 and Day 11 of Period 2Population: PK Analysis Set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, who have received at least one dose of midazolam and who have at least 3 post-dose concentration measurements.
AUC0-t a Pharmacokinetic (PK) parameter was calculated according to the mixed log linear trapezoidal rule.
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Area Under Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Midazolam Metabolite (1-Hydroxymidazolam)
|
30589 h*pg/mL
Geometric Coefficient of Variation 23.8
|
32627 h*pg/mL
Geometric Coefficient of Variation 25.1
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 43 hours post-dose on Day 1 of period 1 and Day 11 of Period 2Population: PK Analysis Set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, who have received at least one dose of midazolam and who have at least 3 post-dose concentration measurements.
AUC0-inf was calculated as AUC0-t plus (+) AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clastpred/Lambda z, where Clastpred is the predicted plasma concentration at the last sampling time point, calculated from the log-linear regression line for Lambda z determination at which the measured plasma concentration is at or above Lower limit of quantification (LLOQ).
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Midazolam Metabolite (1-Hydroxymidazolam)
|
31269 h*pg/mL
Geometric Coefficient of Variation 23.0
|
33372 h*pg/mL
Geometric Coefficient of Variation 24.4
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 43 hours post-dose on Day 1 of period 1 and Day 11 of Period 2Population: PK Analysis Set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, who have received at least one dose of midazolam and who have at least 3 post-dose concentration measurements.
Cmax was obtained directly from concentration versus time curve.
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Midazolam Metabolite (1-Hydroxymidazolam)
|
14909 pg/mL
Geometric Coefficient of Variation 60.4
|
15852 pg/mL
Geometric Coefficient of Variation 34.7
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 43 hours post-dose on Day 1 of period 1 and Day 11 of Period 2Population: PK Analysis Set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, who have received at least one dose of midazolam and who have at least 3 post-dose concentration measurements.
Metabolic ratio was calculated as AUC 0-infinity of midazolam divided by AUC 0-infinity of 1-hydroxymidazolam.
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Metabolic Ratio of Midazolam and Midazolam Metabolite (1-hydroxymidazolam)
|
0.286 ratio
Geometric Coefficient of Variation 37.2
|
0.302 ratio
Geometric Coefficient of Variation 34.3
|
SECONDARY outcome
Timeframe: Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)Population: Safety Analysis Set included all participants who have received atleast 1 dose of planned investigational medicinal product (IMP). Participants was analyzed according to the actual treatment they receive.
Adverse event (AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event (SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs.
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death
TEAEs
|
1 Participants
|
10 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death
Serious TEAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death
TEAEs Leading to Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Screening up to the End of Trial visit (Day 20)Population: Safety Analysis Set included all participants who have received atleast 1 dose of planned IMP. Participants was analyzed according to the actual treatment they receive.
Number of participants with clinically significant changes in laboratory values were reported. Clinical significance was decided by the investigator. Laboratory investigation included hematology and urinalysis.
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Laboratory Values
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period 1) up to the End of Trial visit (Day 20)Population: Safety Analysis Set included all participants who have received atleast 1 dose of planned IMP. Participants was analyzed according to the actual treatment they receive.
Number of participants with clinically significant changes in 12-lead ECG were reported. Clinical significance was decided by the investigator. The 12-lead ECGs were recorded after the participants have rested for at least 5 minute in supine position.
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period 1) up to the End of Trial visit (Day 20)Population: Safety Analysis Set included all participants who have received atleast 1 dose of planned IMP. Participants was analyzed according to the actual treatment they receive.
Number of participants with clinically significant changes in vital signs were reported. Clinical significance was decided by Investigator. Vital signs included body temperature, blood pressure and pulse rate.
Outcome measures
| Measure |
Midazolam (Reference Treatment)
n=12 Participants
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 Participants
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs
|
0 Participants
|
0 Participants
|
Adverse Events
Midazolam (Reference Treatment)
Tepotinib + Midazolam (Test Treatment)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Midazolam (Reference Treatment)
n=12 participants at risk
Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
|
Tepotinib + Midazolam (Test Treatment)
n=12 participants at risk
All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
8.3%
1/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
16.7%
2/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
8.3%
1/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
33.3%
4/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
33.3%
4/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
8.3%
1/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
8.3%
1/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
|
General disorders
Medical device site reaction
|
8.3%
1/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
0.00%
0/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
41.7%
5/12 • Baseline (Day 1 of treatment period 1) up to the End of Trial visit (Day 20)
|
Additional Information
Communication Center
Merck KGaA, Darmstadt, Germany
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER