Trial Outcomes & Findings for A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food (NCT NCT06624072)
NCT ID: NCT06624072
Last Updated: 2026-01-08
Results Overview
AUC0-tz (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point) for Treatment T1 vs Reference R is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% confidence interval (CI).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed.
Results posted on
2026-01-08
Participant Flow
This trial was an open-label, single dose, 3-way crossover design. Subjects were randomly allocated to one of 3 treatment sequences. Each subject participated in 3 treatment periods, receiving a single dose in each, with a washout period of at least 7 days between treatments.
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 |
Nerandomilast (18 mg) in Treatment Sequence R-T1-T2
Participants first received a single oral dose of 1 tablet of 18 milligrams (mg) nerandomilast adult formulation in the fasted state (Reference treatment, R), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (Treatment, T1), and then 18 tablets of 1 mg of nerandomilast pediatric formulation in the fed state as a single oral dose (Treatment, T2).
Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (hrs) for R and T1, or after a high-fat, high-calorie breakfast for T2.
|
Nerandomilast (18 mg) in Treatment Sequence T1-T2-R
Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), and then a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R).
Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2.
|
Nerandomilast (18 mg) in Treatment Sequence T2-R-T1
Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), followed by a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R), and then a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1).
Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2.
|
|---|---|---|---|
|
Treatment Period 1
STARTED
|
5
|
5
|
5
|
|
Treatment Period 1
COMPLETED
|
5
|
5
|
5
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period 1 (7 days)
STARTED
|
5
|
5
|
5
|
|
Washout Period 1 (7 days)
COMPLETED
|
5
|
5
|
4
|
|
Washout Period 1 (7 days)
NOT COMPLETED
|
0
|
0
|
1
|
|
Treatment Period 2
STARTED
|
5
|
5
|
4
|
|
Treatment Period 2
COMPLETED
|
5
|
5
|
4
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period 2 (7 days)
STARTED
|
5
|
5
|
5
|
|
Washout Period 2 (7 days)
COMPLETED
|
5
|
5
|
5
|
|
Washout Period 2 (7 days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
5
|
5
|
5
|
|
Treatment Period 3
COMPLETED
|
5
|
5
|
5
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Nerandomilast (18 mg) in Treatment Sequence R-T1-T2
Participants first received a single oral dose of 1 tablet of 18 milligrams (mg) nerandomilast adult formulation in the fasted state (Reference treatment, R), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (Treatment, T1), and then 18 tablets of 1 mg of nerandomilast pediatric formulation in the fed state as a single oral dose (Treatment, T2).
Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (hrs) for R and T1, or after a high-fat, high-calorie breakfast for T2.
|
Nerandomilast (18 mg) in Treatment Sequence T1-T2-R
Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), and then a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R).
Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2.
|
Nerandomilast (18 mg) in Treatment Sequence T2-R-T1
Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), followed by a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R), and then a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1).
Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2.
|
|---|---|---|---|
|
Washout Period 1 (7 days)
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food
Baseline characteristics by cohort
| Measure |
Nerandomilast (18 mg) in Treatment Sequence R-T1-T2
n=5 Participants
Participants first received a single oral dose of 1 tablet of 18 milligrams (mg) nerandomilast adult formulation in the fasted state (Reference treatment, R), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (Treatment, T1), and then 18 tablets of 1 mg of nerandomilast pediatric formulation in the fed state as a single oral dose (Treatment, T2).
Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (hrs) for R and T1, or after a high-fat, high-calorie breakfast for T2.
|
Nerandomilast (18 mg) in Treatment Sequence T1-T2-R
n=5 Participants
Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), and then a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R).
Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2.
|
Nerandomilast (18 mg) in Treatment Sequence T2-R-T1
n=5 Participants
Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), followed by a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R), and then a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1).
Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.2 Years
STANDARD_DEVIATION 10.5 • n=18 Participants
|
37.8 Years
STANDARD_DEVIATION 10.1 • n=17 Participants
|
39.8 Years
STANDARD_DEVIATION 8.6 • n=35 Participants
|
39.3 Years
STANDARD_DEVIATION 9.1 • n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=18 Participants
|
3 Participants
n=17 Participants
|
5 Participants
n=35 Participants
|
12 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=18 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=18 Participants
|
5 Participants
n=17 Participants
|
5 Participants
n=35 Participants
|
15 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=18 Participants
|
5 Participants
n=17 Participants
|
5 Participants
n=35 Participants
|
15 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Only participants with available data were analyzed.
AUC0-tz (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point) for Treatment T1 vs Reference R is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% confidence interval (CI).
Outcome measures
| Measure |
Nerandomilast 18 mg Ped Fed State (Treatment T2)
n=15 Participants
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state.
|
Nerandomilast 18 mg Ped Fasted State (Treatment T1)
n=14 Participants
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state.
|
|---|---|---|
|
AUC0-tz (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Treatment T1 vs Reference R
|
2732.81 hours*nanomoles/Liter (h·nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.09
|
2647.2 hours*nanomoles/Liter (h·nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.09
|
PRIMARY outcome
Timeframe: Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment.
AUC0-tz (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point) for Treatment T2 vs T1 is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI.
Outcome measures
| Measure |
Nerandomilast 18 mg Ped Fed State (Treatment T2)
n=15 Participants
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state.
|
Nerandomilast 18 mg Ped Fasted State (Treatment T1)
n=15 Participants
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state.
|
|---|---|---|
|
AUC0-tz (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Treatment T2 vs T1
|
2611.55 hours*nanomoles/Liter (h·nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.09
|
2732.81 hours*nanomoles/Liter (h·nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.09
|
PRIMARY outcome
Timeframe: Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Only participants with available data were analyzed.
Cmax (maximum measured concentration of nerandomilast in plasma) for Treatment T1 vs Reference R is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI.
Outcome measures
| Measure |
Nerandomilast 18 mg Ped Fed State (Treatment T2)
n=15 Participants
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state.
|
Nerandomilast 18 mg Ped Fasted State (Treatment T1)
n=14 Participants
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state.
|
|---|---|---|
|
Cmax (Maximum Measured Concentration of Nerandomilast in Plasma) for Treatment T1 vs Reference R
|
501.74 nanomoles/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.10
|
480.85 nanomoles/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.10
|
PRIMARY outcome
Timeframe: Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment.
Cmax (maximum measured concentration of nerandomilast in plasma) for Treatment T2 vs T1 is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI.
Outcome measures
| Measure |
Nerandomilast 18 mg Ped Fed State (Treatment T2)
n=15 Participants
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state.
|
Nerandomilast 18 mg Ped Fasted State (Treatment T1)
n=15 Participants
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state.
|
|---|---|---|
|
Cmax (Maximum Measured Concentration of Nerandomilast in Plasma) for Treatment T2 vs T1
|
344.76 nanomoles/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.07
|
501.74 nanomoles/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.07
|
SECONDARY outcome
Timeframe: Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Only participants with available data were analyzed.
AUC0-∞ (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity) for Treatment T1 vs Reference R is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI.
Outcome measures
| Measure |
Nerandomilast 18 mg Ped Fed State (Treatment T2)
n=15 Participants
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state.
|
Nerandomilast 18 mg Ped Fasted State (Treatment T1)
n=14 Participants
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state.
|
|---|---|---|
|
AUC0-∞ (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity) for Treatment T1 vs Reference R
|
2748.78 hours*nanomoles/Liter (h·nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.09
|
2667.20 hours*nanomoles/Liter (h·nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.09
|
SECONDARY outcome
Timeframe: Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment.
AUC0-∞ (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity) for Treatment T2 vs T1 is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI.
Outcome measures
| Measure |
Nerandomilast 18 mg Ped Fed State (Treatment T2)
n=15 Participants
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state.
|
Nerandomilast 18 mg Ped Fasted State (Treatment T1)
n=15 Participants
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state.
|
|---|---|---|
|
AUC0-∞ (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity) for Treatment T2 vs T1
|
2631.39 hours*nanomoles/Liter (h·nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.09
|
2748.78 hours*nanomoles/Liter (h·nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.09
|
Adverse Events
Nerandomilast 18 mg Adult Fasted State (Reference R)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Nerandomilast 18 mg Ped Fasted State (Treatment T1)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Nerandomilast 18 mg Ped Fed State (Treatment T2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nerandomilast 18 mg Adult Fasted State (Reference R)
n=14 participants at risk
Participants received a single oral dose of 1 tablet of 18 mg nerandomilast adult formulation in the fasted state.
|
Nerandomilast 18 mg Ped Fasted State (Treatment T1)
n=15 participants at risk
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state.
|
Nerandomilast 18 mg Ped Fed State (Treatment T2)
n=15 participants at risk
Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
13.3%
2/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
6.7%
1/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
13.3%
2/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
13.3%
2/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
13.3%
2/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
General disorders
Peripheral swelling
|
0.00%
0/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
6.7%
1/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
6.7%
1/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
6.7%
1/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
6.7%
1/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
6.7%
1/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
13.3%
2/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Nervous system disorders
Headache
|
28.6%
4/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
46.7%
7/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
40.0%
6/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
6.7%
1/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
6.7%
1/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
6.7%
1/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
7.1%
1/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
13.3%
2/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
|
Vascular disorders
Haematoma
|
0.00%
0/14 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
0.00%
0/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
6.7%
1/15 • Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place