Trial Outcomes & Findings for A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body (NCT NCT06494761)
NCT ID: NCT06494761
Last Updated: 2025-12-02
Results Overview
The area under the concentration-time curve of repaglinide in plasma over the time interval from 0 extrapolated to infinity ((AUC0-∞) is reported. Period 1 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 14): ≤15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 2.5, 3-, 4-,6-, and 24-hours post-dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Samples were collected on Day 1 (Period 1), Day 1 (Period 2), and Day 14 (Period 2). See endpoint description for the full sampling schedule
Results posted on
2025-12-02
Participant Flow
This non-randomized, open-label, two-period, fixed-sequence trial evaluated the effect of multiple oral doses of zongertinib on the single-dose pharmacokinetics of midazolam, omeprazole, and repaglinide in healthy male subjects to assess potential drug-drug interactions.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test)
Reference (Repaglinide + Midazolam + Omeprazole)
In the reference treatment period (Period 1), participants received 0.5 mg repaglinide tablet (Day 1, after ≥10 h fast; Reference Treatment 1). On Day 2, they received 1 mg midazolam (0.5 mL oral solution) with 20 mg omeprazole tablet under the same fasting conditions (Reference Treatment 2).
Test (Zongertinib + Repaglinide + Midazolam + Omeprazole)
In the test treatment period (Period 2), participants received multiple once-daily doses of 120 mg zongertinib from Day 1 to Day 15. A single 0.5 mg repaglinide tablet was co-administered on Day 1 (Test Treatment 1) and Day 14 (Test Treatment 3), and a single dose of the probe drug cocktail containing 1 mg midazolam (0.5 mL oral solution) and 20 mg omeprazole tablet was co-administered on Day 2 (Test Treatment 2) and Day 15 (Test Treatment 4).
|
|---|---|
|
Period 1 (Reference Period) (3 days)
STARTED
|
16
|
|
Period 1 (Reference Period) (3 days)
COMPLETED
|
16
|
|
Period 1 (Reference Period) (3 days)
NOT COMPLETED
|
0
|
|
Washout (3 days)
STARTED
|
16
|
|
Washout (3 days)
COMPLETED
|
16
|
|
Washout (3 days)
NOT COMPLETED
|
0
|
|
Period 2: (Test Period) (15 days)
STARTED
|
16
|
|
Period 2: (Test Period) (15 days)
COMPLETED
|
14
|
|
Period 2: (Test Period) (15 days)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test)
Reference (Repaglinide + Midazolam + Omeprazole)
In the reference treatment period (Period 1), participants received 0.5 mg repaglinide tablet (Day 1, after ≥10 h fast; Reference Treatment 1). On Day 2, they received 1 mg midazolam (0.5 mL oral solution) with 20 mg omeprazole tablet under the same fasting conditions (Reference Treatment 2).
Test (Zongertinib + Repaglinide + Midazolam + Omeprazole)
In the test treatment period (Period 2), participants received multiple once-daily doses of 120 mg zongertinib from Day 1 to Day 15. A single 0.5 mg repaglinide tablet was co-administered on Day 1 (Test Treatment 1) and Day 14 (Test Treatment 3), and a single dose of the probe drug cocktail containing 1 mg midazolam (0.5 mL oral solution) and 20 mg omeprazole tablet was co-administered on Day 2 (Test Treatment 2) and Day 15 (Test Treatment 4).
|
|---|---|
|
Period 2: (Test Period) (15 days)
Adverse Event
|
1
|
|
Period 2: (Test Period) (15 days)
Physician Decision
|
1
|
Baseline Characteristics
A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body
Baseline characteristics by cohort
| Measure |
Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test)
n=16 Participants
Reference (Repaglinide + Midazolam + Omeprazole)
In the reference treatment period (Period 1), participants received 0.5 mg repaglinide tablet (Day 1, after ≥10 h fast; Reference Treatment 1). On Day 2, they received 1 mg midazolam (0.5 mL oral solution) with 20 mg omeprazole tablet under the same fasting conditions (Reference Treatment 2).
Test (Zongertinib + Repaglinide + Midazolam + Omeprazole)
In the test treatment period (Period 2), participants received multiple once-daily doses of 120 mg zongertinib from Day 1 to Day 15. A single 0.5 mg repaglinide tablet was co-administered on Day 1 (Test Treatment 1) and Day 14 (Test Treatment 3), and a single dose of the probe drug cocktail containing 1 mg midazolam (0.5 mL oral solution) and 20 mg omeprazole tablet was co-administered on Day 2 (Test Treatment 2) and Day 15 (Test Treatment 4).
|
|---|---|
|
Age, Continuous
|
35.6 Years
STANDARD_DEVIATION 12.1 • n=121 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=121 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=121 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
PRIMARY outcome
Timeframe: Samples were collected on Day 1 (Period 1), Day 1 (Period 2), and Day 14 (Period 2). See endpoint description for the full sampling schedulePopulation: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment 3 Arm.
The area under the concentration-time curve of repaglinide in plasma over the time interval from 0 extrapolated to infinity ((AUC0-∞) is reported. Period 1 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 14): ≤15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 2.5, 3-, 4-,6-, and 24-hours post-dose.
Outcome measures
| Measure |
Midazolam + Omeprazole (Reference Treatment 2)
n=16 Participants
In the reference treatment period (Period 1), participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 following an overnight fast of at least 10 hours.
|
Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)
n=14 Participants
In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.
|
Repaglinide with a single dose of zongertinib (Test Treatment 1)
n=16 Participants
In the test treatment period (Period 2), Day 1, participants received a single 0.5 mg dose of repaglinide coadministered with a single 120 mg dose of zongertinib (two 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞)
|
28100 Hours × picomoles per liter (h*pmol/L)
Geometric Coefficient of Variation 58.0
|
37300 Hours × picomoles per liter (h*pmol/L)
Geometric Coefficient of Variation 48.7
|
31200 Hours × picomoles per liter (h*pmol/L)
Geometric Coefficient of Variation 49.2
|
PRIMARY outcome
Timeframe: Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedulePopulation: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment Arm 2 and 3.
The area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity ((AUC0-∞) is reported. Period 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.
Outcome measures
| Measure |
Midazolam + Omeprazole (Reference Treatment 2)
n=16 Participants
In the reference treatment period (Period 1), participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 following an overnight fast of at least 10 hours.
|
Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)
n=14 Participants
In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.
|
Repaglinide with a single dose of zongertinib (Test Treatment 1)
n=14 Participants
In the test treatment period (Period 2), Day 1, participants received a single 0.5 mg dose of repaglinide coadministered with a single 120 mg dose of zongertinib (two 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞)
|
41400 Hours × picomoles per liter (h*pmol/L)
Geometric Coefficient of Variation 33.5
|
43400 Hours × picomoles per liter (h*pmol/L)
Geometric Coefficient of Variation 27.9
|
44200 Hours × picomoles per liter (h*pmol/L)
Geometric Coefficient of Variation 37.3
|
PRIMARY outcome
Timeframe: Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedulePopulation: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with evaluable results were reported.
The area under the concentration-time curve of omeprazole in plasma over the time interval from 0 extrapolated to infinity ((AUC0-∞) is reported. Period 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.
Outcome measures
| Measure |
Midazolam + Omeprazole (Reference Treatment 2)
n=10 Participants
In the reference treatment period (Period 1), participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 following an overnight fast of at least 10 hours.
|
Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)
n=9 Participants
In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.
|
Repaglinide with a single dose of zongertinib (Test Treatment 1)
n=10 Participants
In the test treatment period (Period 2), Day 1, participants received a single 0.5 mg dose of repaglinide coadministered with a single 120 mg dose of zongertinib (two 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞)
|
378 hour * nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 69.7
|
296 hour * nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 60.2
|
359 hour * nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 66.9
|
PRIMARY outcome
Timeframe: Samples were collected on Day 1 (Period 1), Day 1 (Period 2), and Day 14 (Period 2). See endpoint description for the full sampling schedulePopulation: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment 3 Arm.
The maximum measured concentration of repaglinide in plasma is reported. Period 1 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 14): ≤15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 2.5, 3-, 4-,6-, and 24-hours post-dose.
Outcome measures
| Measure |
Midazolam + Omeprazole (Reference Treatment 2)
n=16 Participants
In the reference treatment period (Period 1), participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 following an overnight fast of at least 10 hours.
|
Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)
n=14 Participants
In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.
|
Repaglinide with a single dose of zongertinib (Test Treatment 1)
n=16 Participants
In the test treatment period (Period 2), Day 1, participants received a single 0.5 mg dose of repaglinide coadministered with a single 120 mg dose of zongertinib (two 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Maximum Measured Concentration of Repaglinide in Plasma (Cmax)
|
20200 Picomoles per liter (pmol/L)
Geometric Coefficient of Variation 52.6
|
29700 Picomoles per liter (pmol/L)
Geometric Coefficient of Variation 36.8
|
23600 Picomoles per liter (pmol/L)
Geometric Coefficient of Variation 40.9
|
PRIMARY outcome
Timeframe: Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedulePopulation: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment Arm 2 and 3.
The maximum measured concentration of midazolam in plasma is reported. Period 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.
Outcome measures
| Measure |
Midazolam + Omeprazole (Reference Treatment 2)
n=16 Participants
In the reference treatment period (Period 1), participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 following an overnight fast of at least 10 hours.
|
Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)
n=14 Participants
In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.
|
Repaglinide with a single dose of zongertinib (Test Treatment 1)
n=14 Participants
In the test treatment period (Period 2), Day 1, participants received a single 0.5 mg dose of repaglinide coadministered with a single 120 mg dose of zongertinib (two 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Maximum Measured Concentration of Midazolam in Plasma (Cmax)
|
17700 Picomoles per liter (pmol/L)
Geometric Coefficient of Variation 25.8
|
20800 Picomoles per liter (pmol/L)
Geometric Coefficient of Variation 26.0
|
19700 Picomoles per liter (pmol/L)
Geometric Coefficient of Variation 33.0
|
PRIMARY outcome
Timeframe: Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedulePopulation: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with evaluable results were reported.
The maximum measured concentration of omeprazole in plasma is reported. Period 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.
Outcome measures
| Measure |
Midazolam + Omeprazole (Reference Treatment 2)
n=15 Participants
In the reference treatment period (Period 1), participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 following an overnight fast of at least 10 hours.
|
Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)
n=13 Participants
In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.
|
Repaglinide with a single dose of zongertinib (Test Treatment 1)
n=13 Participants
In the test treatment period (Period 2), Day 1, participants received a single 0.5 mg dose of repaglinide coadministered with a single 120 mg dose of zongertinib (two 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Maximum Measured Concentration of Omeprazole in Plasma (Cmax)
|
165 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 91.7
|
101 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 79.3
|
131 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 78.3
|
SECONDARY outcome
Timeframe: Samples were collected on Day 1 (Period 1), Day 1 (Period 2), and Day 14 (Period 2). See endpoint description for the full sampling schedulePopulation: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment 3 Arm.
The area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data poin is reported. Period 1 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 14): ≤15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 2.5, 3-, 4-,6-, and 24-hours post-dose.
Outcome measures
| Measure |
Midazolam + Omeprazole (Reference Treatment 2)
n=16 Participants
In the reference treatment period (Period 1), participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 following an overnight fast of at least 10 hours.
|
Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)
n=14 Participants
In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.
|
Repaglinide with a single dose of zongertinib (Test Treatment 1)
n=16 Participants
In the test treatment period (Period 2), Day 1, participants received a single 0.5 mg dose of repaglinide coadministered with a single 120 mg dose of zongertinib (two 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
27700 Hours × picomoles per liter (h*pmol/L)
Geometric Coefficient of Variation 58.3
|
36700 Hours × picomoles per liter (h*pmol/L)
Geometric Coefficient of Variation 48.7
|
30700 Hours × picomoles per liter (h*pmol/L)
Geometric Coefficient of Variation 50.5
|
SECONDARY outcome
Timeframe: Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedulePopulation: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment Arm 2 and 3.
The area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point is reported. Period 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.
Outcome measures
| Measure |
Midazolam + Omeprazole (Reference Treatment 2)
n=16 Participants
In the reference treatment period (Period 1), participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 following an overnight fast of at least 10 hours.
|
Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)
n=14 Participants
In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.
|
Repaglinide with a single dose of zongertinib (Test Treatment 1)
n=14 Participants
In the test treatment period (Period 2), Day 1, participants received a single 0.5 mg dose of repaglinide coadministered with a single 120 mg dose of zongertinib (two 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
39600 Hours × picomoles per liter (h*pmol/L)
Geometric Coefficient of Variation 33.6
|
41700 Hours × picomoles per liter (h*pmol/L)
Geometric Coefficient of Variation 27.7
|
42700 Hours × picomoles per liter (h*pmol/L)
Geometric Coefficient of Variation 38.1
|
SECONDARY outcome
Timeframe: Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedulePopulation: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with evaluable results were reported.
The area under the concentration-time curve of omeprazole in plasma over the time interval from 0 to the last quantifiable data point is reported. Period 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.
Outcome measures
| Measure |
Midazolam + Omeprazole (Reference Treatment 2)
n=15 Participants
In the reference treatment period (Period 1), participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 following an overnight fast of at least 10 hours.
|
Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)
n=13 Participants
In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.
|
Repaglinide with a single dose of zongertinib (Test Treatment 1)
n=13 Participants
In the test treatment period (Period 2), Day 1, participants received a single 0.5 mg dose of repaglinide coadministered with a single 120 mg dose of zongertinib (two 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
287 h*ng/mL
Geometric Coefficient of Variation 78.3
|
267 h*ng/mL
Geometric Coefficient of Variation 61.8
|
304 h*ng/mL
Geometric Coefficient of Variation 72.8
|
Adverse Events
Repaglinide (Reference Treatment 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Midazolam + Omeprazole (Reference Treatment 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Zongertinib +Repaglinide (Test Treatment 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Zongertinib +Midazolam +Omeprazole (Test Treatment 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Zongertinib
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Zongertinib +Repaglinide (Test Treatment 3)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Zongertinib + Midazolam + Omeprazole (Test Treatment 4)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Repaglinide (Reference Treatment 1)
n=16 participants at risk
Participants received a single 0.5 mg repaglinide tablet on Day 1 of Period 1, after an overnight fast of at least 10 hours.
|
Midazolam + Omeprazole (Reference Treatment 2)
n=16 participants at risk
Participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 of Period 1, following an overnight fast of at least 10 hours.
|
Zongertinib +Repaglinide (Test Treatment 1)
n=16 participants at risk
Participants received 120 mg zongertinib (two 60 mg tablets) and a single 0.5 mg repaglinide tablet on Day 1 of Period 2, after an overnight fast of at least 10 hours.
|
Zongertinib +Midazolam +Omeprazole (Test Treatment 2)
n=14 participants at risk
Participants received 120 mg zongertinib (two 60 mg tablets) on Day 1. On Day 2, after one day of zongertinib pretreatment, participants were administered 1 mg, midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.
|
Zongertinib
n=14 participants at risk
Participants received 120 mg zongertinib daily (as two 60 mg tablets) from Day 1 to Day 15 of Period 2.
|
Zongertinib +Repaglinide (Test Treatment 3)
n=14 participants at risk
Participants received 0.5 mg repaglinide coadministered with zongertinib on Day 14 of Period 2, after 13 days of zongertinib pretreatment and an overnight fast.
|
Zongertinib + Midazolam + Omeprazole (Test Treatment 4)
n=14 participants at risk
Participants received 1 mg midazolam and 20 mg omeprazole coadministered with zongertinib on Day 15 of Period 2, after 14 days of zongertinib pretreatment and an overnight fast.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
14.3%
2/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.2%
1/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
14.3%
2/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
General disorders
Malaise
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.2%
1/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.2%
1/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
12.5%
2/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
21.4%
3/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
6.2%
1/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
14.3%
2/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
14.3%
2/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.2%
1/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
7.1%
1/14 • AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place