Trial Outcomes & Findings for A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood (NCT NCT05380947)
NCT ID: NCT05380947
Last Updated: 2025-11-04
Results Overview
The maximum measured concentration of BI 1810631 in plasma (Cmax) was reported. Unit of geometric coefficient of variation (gCV) is %.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.
Results posted on
2025-11-04
Participant Flow
This study was to investigate the relative bioavailability of 2 different BI 1810631 oral formulations (trial formulation 1 \[TF1\], Reference \[R\] and new formulation \[NF\], Test 1 \[T1\]) under fasting conditions; BI 1810631 NF under fasting (T1) and fed (T2) conditions; BI 1810631 NF given alone (T1) and together with the proton pump inhibitor rabeprazole (T3) under fasting conditions.
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 |
Treatment Sequence 1: R - T1 - T2 - T3
The treatment sequence R-T1-T2-T3 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations.
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition.
T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
Treatment Sequence 2: T1 - T3 - R - T2
The treatment sequence T1 - T3 - R - T2 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations.
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition.
T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
Treatment Sequence 3: T2 - R - T3 - T1
The treatment sequence T2 - R - T3 - T1 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations.
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition.
T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
Treatment Sequence 4: T3 - T2 - T1 - R
The treatment sequence T3 - T2 - T1 - R was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations.
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition.
T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
|---|---|---|---|---|
|
Washout Period 3
COMPLETED
|
1
|
2
|
3
|
2
|
|
Washout Period 3
NOT COMPLETED
|
0
|
2
|
0
|
1
|
|
Period 4
STARTED
|
1
|
2
|
3
|
2
|
|
Period 4
COMPLETED
|
1
|
2
|
3
|
2
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 1
STARTED
|
3
|
4
|
3
|
3
|
|
Period 1
COMPLETED
|
3
|
4
|
3
|
3
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 1
STARTED
|
3
|
4
|
3
|
3
|
|
Washout Period 1
COMPLETED
|
2
|
4
|
3
|
3
|
|
Washout Period 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Period 2
STARTED
|
2
|
4
|
3
|
3
|
|
Period 2
COMPLETED
|
2
|
4
|
3
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2
STARTED
|
2
|
4
|
3
|
3
|
|
Washout Period 2
COMPLETED
|
1
|
4
|
3
|
3
|
|
Washout Period 2
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Period 3
STARTED
|
1
|
4
|
3
|
3
|
|
Period 3
COMPLETED
|
1
|
4
|
3
|
3
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 3
STARTED
|
1
|
4
|
3
|
3
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1: R - T1 - T2 - T3
The treatment sequence R-T1-T2-T3 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations.
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition.
T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
Treatment Sequence 2: T1 - T3 - R - T2
The treatment sequence T1 - T3 - R - T2 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations.
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition.
T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
Treatment Sequence 3: T2 - R - T3 - T1
The treatment sequence T2 - R - T3 - T1 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations.
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition.
T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
Treatment Sequence 4: T3 - T2 - T1 - R
The treatment sequence T3 - T2 - T1 - R was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations.
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition.
T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
|---|---|---|---|---|
|
Washout Period 1
Not attend visit
|
1
|
0
|
0
|
0
|
|
Washout Period 2
Adverse Event
|
1
|
0
|
0
|
0
|
|
Washout Period 3
Adverse Event
|
0
|
1
|
0
|
0
|
|
Washout Period 3
Not attend visit
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1: R - T1 - T2 - T3
n=3 Participants
The treatment sequence R-T1-T2-T3 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations.
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition.
T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
Treatment Sequence 2: T1 - T3 - R - T2
n=4 Participants
The treatment sequence T1 - T3 - R - T2 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations.
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition.
T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
Treatment Sequence 3: T2 - R - T3 - T1
n=3 Participants
The treatment sequence T2 - R - T3 - T1 was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations.
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition.
T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
Treatment Sequence 4: T3 - T2 - T1 - R
n=3 Participants
The treatment sequence T3 - T2 - T1 - R was administered. The treatments were separated by a washout interval of at least 14 days between BI 1810631 administrations.
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
T2: 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fed condition.
T3: 2 gastroresistant tablets of 20 mg Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as NF were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.7 Years
STANDARD_DEVIATION 7.0 • n=15 Participants
|
33.5 Years
STANDARD_DEVIATION 3.1 • n=161 Participants
|
34.7 Years
STANDARD_DEVIATION 8.5 • n=100 Participants
|
34.0 Years
STANDARD_DEVIATION 7.2 • n=3 Participants
|
34.8 Years
STANDARD_DEVIATION 5.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
3 Participants
n=3 Participants
|
13 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
3 Participants
n=3 Participants
|
13 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=15 Participants
|
3 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
3 Participants
n=3 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): this set included all subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis.
The area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) was reported. Unit of geometric coefficient of variation (gCV) is %.
Outcome measures
| Measure |
TF1 Fasted (R)
n=12 Participants
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
NF Fasted (T1)
n=12 Participants
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
NF Fed (T2)
n=9 Participants
Test 2 (T2): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fed condition.
|
NF Fasted + Rabeprazole (T3)
n=11 Participants
Test 3 (T3): 2 gastroresistant tablets of 20 milligrams (mg) Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
4240 hour * nanomole / Liter (h*nmol/L)
Geometric Coefficient of Variation 52.7
|
5680 hour * nanomole / Liter (h*nmol/L)
Geometric Coefficient of Variation 18.8
|
4060 hour * nanomole / Liter (h*nmol/L)
Geometric Coefficient of Variation 13.7
|
5410 hour * nanomole / Liter (h*nmol/L)
Geometric Coefficient of Variation 27.6
|
PRIMARY outcome
Timeframe: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): this set included all subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis.
The maximum measured concentration of BI 1810631 in plasma (Cmax) was reported. Unit of geometric coefficient of variation (gCV) is %.
Outcome measures
| Measure |
TF1 Fasted (R)
n=12 Participants
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
NF Fasted (T1)
n=12 Participants
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
NF Fed (T2)
n=9 Participants
Test 2 (T2): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fed condition.
|
NF Fasted + Rabeprazole (T3)
n=11 Participants
Test 3 (T3): 2 gastroresistant tablets of 20 milligrams (mg) Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1810631 in Plasma (Cmax)
|
291 nanomole / Liter (nmol/L)
Geometric Coefficient of Variation 93.1
|
399 nanomole / Liter (nmol/L)
Geometric Coefficient of Variation 37.3
|
208 nanomole / Liter (nmol/L)
Geometric Coefficient of Variation 31.4
|
327 nanomole / Liter (nmol/L)
Geometric Coefficient of Variation 34.2
|
SECONDARY outcome
Timeframe: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): this set included all subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis.
The area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) was reported. Unit of geometric coefficient of variation (gCV) is %.
Outcome measures
| Measure |
TF1 Fasted (R)
n=11 Participants
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
NF Fasted (T1)
n=12 Participants
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
NF Fed (T2)
n=9 Participants
Test 2 (T2): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fed condition.
|
NF Fasted + Rabeprazole (T3)
n=11 Participants
Test 3 (T3): 2 gastroresistant tablets of 20 milligrams (mg) Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
4550 hour * nanomole / Liter (h * nmol/L)
Geometric Coefficient of Variation 52.7
|
5980 hour * nanomole / Liter (h * nmol/L)
Geometric Coefficient of Variation 19.2
|
4310 hour * nanomole / Liter (h * nmol/L)
Geometric Coefficient of Variation 14.2
|
5660 hour * nanomole / Liter (h * nmol/L)
Geometric Coefficient of Variation 28.8
|
Adverse Events
TF1 Fasted (R)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
NF Fasted (T1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
NF Fed (T2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Rabeprazole
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
NF Fasted + Rabeprazole (T3)
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 |
TF1 Fasted (R)
n=12 participants at risk
Reference (R): 30 mg BI 1810631 as trial formulation 1 (TF1) were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
NF Fasted (T1)
n=12 participants at risk
Test 1 (T1): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
NF Fed (T2)
n=9 participants at risk
Test 2 (T2): 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fed condition.
|
Rabeprazole
n=11 participants at risk
2 gastroresistant tablets of 20 milligrams (mg) Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period.
|
NF Fasted + Rabeprazole (T3)
n=11 participants at risk
Test 3 (T3): 2 gastroresistant tablets of 20 milligrams (mg) Pariet® (rabeprazole; 40 mg per dose) were administered orally once daily over Day -4 to Day 1 (5 days in total) of respective period; 30 mg BI 1810631 as new formulation (NF) were administered orally as single dose once on Day 1 of respective period under fasted condition.
|
|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
16.7%
2/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
8.3%
1/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Infections and infestations
Furuncle
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
9.1%
1/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
9.1%
1/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Infections and infestations
Pharyngitis
|
8.3%
1/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
9.1%
1/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
8.3%
1/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
9.1%
1/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
9.1%
1/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
9.1%
1/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
9.1%
1/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
9.1%
1/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/11 • For R, T1, T2, and NF fasted + Rabeprazole (Rab.): From drug administration (admin.) till end of 14-day residual effect period (REP), up to 14 days. For Rab.: From drug admin. till end of REP of Rab., up to 8 days. All-cause mortality: From the first drug administration till end of trial, up to a total of 64 days.
Treated set (TS): the TS included 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