Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809 (NCT NCT02068690)
NCT ID: NCT02068690
Last Updated: 2026-05-05
Results Overview
Number of participants with drug-related Adverse Events (AE). Drug-relatedness was assessed by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
83 participants
Primary outcome timeframe
SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Results posted on
2026-05-05
Participant Flow
Single-rising dose (SRD) part: partially randomized, single-blind, placebo-controlled groups investigated consecutively in ascending dose order. Participants in second cohort per dose randomized in a 3:1 ratio (active treatment/placebo). Bioavailability/Food Effect (BA/FE) part: open-label, randomized, 3-way cross-over design. Treatments: BI 425809 as a tablet without food (R), a tablet with food (T1), and powder in oral solution without food (T2) in 1 of 6 sequences in a 1:1:1:1:1:1 ratio.
All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they (the participants) strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
SRD Part: Placebo
Participants received a single dose of oral solution of placebo matching BI 425809.
|
SRD Part: 0.5 mg BI 425809
Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809.
|
SRD Part: 1 mg BI 425809
Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809.
|
SRD Part: 2 mg BI 425809
Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809.
|
SRD Part: 5 mg BI 425809
Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809.
|
SRD Part: 10 mg BI425809
Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809.
|
SRD Part: 25 mg BI 425809
Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809.
|
SRD Part: 50 mg BI 425809
Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809.
|
SRD Part: 100 mg BI 425809
Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
BA/FE Part: 25 mg BI 425809, R/T1/T2
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days.
|
BA/FE Part: 25 mg BI 425809, R/T2/T1
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days.
|
BA/FE Part: 25 mg BI 425809, T1/T2/R
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days.
|
BA/FE Part: 25 mg BI 425809, T1/R/T2
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days.
|
BA/FE Part: 25 mg BI 425809, T2/T1/R
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days.
|
BA/FE Part: 25 mg BI 425809, T2/R/T1
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
2
|
2
|
2
|
2
|
2
|
1
|
|
Overall Study
COMPLETED
|
18
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
2
|
2
|
2
|
2
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809
Baseline characteristics by cohort
| Measure |
SRD Part: Placebo
n=18 Participants
Participants received a single dose of oral solution of placebo matching BI 425809.
|
SRD Part: 0.5 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809.
|
SRD Part: 1 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809.
|
SRD Part: 2 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809.
|
SRD Part: 5 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809.
|
SRD Part: 10 mg BI425809
n=6 Participants
Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809.
|
SRD Part: 25 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809.
|
SRD Part: 50 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809.
|
SRD Part: 100 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
BA/FE Part
n=11 Participants
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1) and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days.
Participants were randomly allocated to 1 of the 6 treatment sequences: R/T1/T2, R/T2/T1, T1/T2/R, T1/R/T2, T2/T1/R, or T2/R/T1.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 8.4 • n=54 Participants
|
31.5 years
STANDARD_DEVIATION 10.4 • n=60 Participants
|
33.8 years
STANDARD_DEVIATION 5.6 • n=114 Participants
|
29.3 years
STANDARD_DEVIATION 8.0 • n=37 Participants
|
29.3 years
STANDARD_DEVIATION 3.6 • n=24 Participants
|
25.0 years
STANDARD_DEVIATION 4.2 • n=19 Participants
|
33.5 years
STANDARD_DEVIATION 9.9 • n=88 Participants
|
38.5 years
STANDARD_DEVIATION 4.1 • n=6 Participants
|
31.7 years
STANDARD_DEVIATION 6.5 • n=15 Participants
|
31.8 years
STANDARD_DEVIATION 6.1 • n=55 Participants
|
31.7 years
STANDARD_DEVIATION 9.3 • n=14 Participants
|
32.5 years
STANDARD_DEVIATION 7.9 • n=15 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
6 Participants
n=37 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=19 Participants
|
6 Participants
n=88 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=15 Participants
|
6 Participants
n=55 Participants
|
11 Participants
n=14 Participants
|
83 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
6 Participants
n=37 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=19 Participants
|
6 Participants
n=88 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=15 Participants
|
6 Participants
n=55 Participants
|
11 Participants
n=14 Participants
|
83 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.Population: Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
Number of participants with drug-related Adverse Events (AE). Drug-relatedness was assessed by the investigator.
Outcome measures
| Measure |
SRD Part: 0.5 mg BI 425809
n=18 Participants
Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809.
|
SRD Part: 1 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809.
|
SRD Part: 2 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809.
|
SRD Part: 5 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809.
|
SRD Part: 10 mg BI425809
n=6 Participants
Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809.
|
SRD Part: 25 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809.
|
SRD Part: 50 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809.
|
SRD Part: 100 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
BA/FE Part: Tablet Without Food
n=11 Participants
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R).
|
BA/FE Part: Tablet With Food
n=11 Participants
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1).
|
BA/FE Part: Oral Solution Without Food
n=11 Participants
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Drug-related Adverse Events (AE)
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.Population: Pharmacokinetic set-Dose proportionality (PKS-DP): included all participants of the TS-SRD (Treated Set-Single Rising Dose) on active treatment who provided at least 1 observation for at least 1 of the secondary PK endpoints (Cmax, AUC(0-∞)) without important protocol violations relevant to the statistical evaluation of DP.
Maximum measured concentration of BI 425809 in plasma (Cmax) in the Single Rising Dose (SRD) part of the trial is reported.
Outcome measures
| Measure |
SRD Part: 0.5 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809.
|
SRD Part: 1 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809.
|
SRD Part: 2 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809.
|
SRD Part: 5 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809.
|
SRD Part: 10 mg BI425809
n=6 Participants
Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809.
|
SRD Part: 25 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809.
|
SRD Part: 50 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809.
|
SRD Part: 100 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
BA/FE Part: Tablet Without Food
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R).
|
BA/FE Part: Tablet With Food
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1).
|
BA/FE Part: Oral Solution Without Food
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRD Part: Maximum Concentration of BI 425809 in Plasma (Cmax)
|
10.0 Nanomole/Liter
Geometric Coefficient of Variation 27.6
|
21.5 Nanomole/Liter
Geometric Coefficient of Variation 17.4
|
42.3 Nanomole/Liter
Geometric Coefficient of Variation 23.3
|
89.0 Nanomole/Liter
Geometric Coefficient of Variation 24.6
|
171 Nanomole/Liter
Geometric Coefficient of Variation 11.7
|
417 Nanomole/Liter
Geometric Coefficient of Variation 30.6
|
865 Nanomole/Liter
Geometric Coefficient of Variation 23.9
|
1650 Nanomole/Liter
Geometric Coefficient of Variation 25.6
|
2970 Nanomole/Liter
Geometric Coefficient of Variation 29.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.Population: Pharmacokinetic Set-Bioavailability/Food Effect (PKS-BA/FE): included all participants of the TS-BA/FE (Treated Set-Bioavailability/Food Effect) on active treatment who provided at least 1 observation for at least 1 of the secondary PK endpoints (Cmax, AUC(0-∞)) without important protocol violations relevant to the statistical evaluation of BA/FE.
Maximum measured concentration of BI 425809 in plasma (Cmax) in the bioavailability/food effect (BA/FE) part of the trial is reported.
Outcome measures
| Measure |
SRD Part: 0.5 mg BI 425809
n=11 Participants
Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809.
|
SRD Part: 1 mg BI 425809
n=10 Participants
Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809.
|
SRD Part: 2 mg BI 425809
n=10 Participants
Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809.
|
SRD Part: 5 mg BI 425809
Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809.
|
SRD Part: 10 mg BI425809
Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809.
|
SRD Part: 25 mg BI 425809
Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809.
|
SRD Part: 50 mg BI 425809
Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809.
|
SRD Part: 100 mg BI 425809
Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
BA/FE Part: Tablet Without Food
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R).
|
BA/FE Part: Tablet With Food
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1).
|
BA/FE Part: Oral Solution Without Food
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
BA/FE Part: Maximum Concentration of BI 425809 in Plasma (Cmax)
|
223 Nanomole/Liter
Geometric Coefficient of Variation 13.4
|
329 Nanomole/Liter
Geometric Coefficient of Variation 19.9
|
443 Nanomole/Liter
Geometric Coefficient of Variation 26.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.Population: Pharmacokinetic Set-Dose Proportionality (PKS-DP): included all participants of the TS-SRD (Treated Set-Single Rising Dose) on active treatment who provided at least 1 observation for at least 1 of the secondary PK endpoints (Cmax, AUC(0-∞)) without important protocol violations relevant to the statistical evaluation of DP.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Single Rising Dose (SRD) part of the trial is reported.
Outcome measures
| Measure |
SRD Part: 0.5 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809.
|
SRD Part: 1 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809.
|
SRD Part: 2 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809.
|
SRD Part: 5 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809.
|
SRD Part: 10 mg BI425809
n=6 Participants
Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809.
|
SRD Part: 25 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809.
|
SRD Part: 50 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809.
|
SRD Part: 100 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
n=6 Participants
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
BA/FE Part: Tablet Without Food
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R).
|
BA/FE Part: Tablet With Food
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1).
|
BA/FE Part: Oral Solution Without Food
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRD Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))
|
187 Nanomole*Hour/Liter
Geometric Coefficient of Variation 19.2
|
404 Nanomole*Hour/Liter
Geometric Coefficient of Variation 27.2
|
789 Nanomole*Hour/Liter
Geometric Coefficient of Variation 36.1
|
1990 Nanomole*Hour/Liter
Geometric Coefficient of Variation 32.4
|
4500 Nanomole*Hour/Liter
Geometric Coefficient of Variation 15.7
|
8500 Nanomole*Hour/Liter
Geometric Coefficient of Variation 19.3
|
16900 Nanomole*Hour/Liter
Geometric Coefficient of Variation 23.8
|
39400 Nanomole*Hour/Liter
Geometric Coefficient of Variation 27.2
|
48500 Nanomole*Hour/Liter
Geometric Coefficient of Variation 24.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.Population: Pharmacokinetic Set-Bioavailability/Food Effect (PKS-BA/FE): included all subjects of the TS-BA/FE (Treated Set-Bioavailability/Food Effect) on active treatment who provided at least 1 observation for at least 1 of the secondary PK endpoints (Cmax, AUC(0-∞)) without important protocol violations relevant to the statistical evaluation of BA/FE.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Bioavailability/Food Effect (BA/FE) part of the trial is reported.
Outcome measures
| Measure |
SRD Part: 0.5 mg BI 425809
n=11 Participants
Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809.
|
SRD Part: 1 mg BI 425809
n=10 Participants
Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809.
|
SRD Part: 2 mg BI 425809
n=10 Participants
Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809.
|
SRD Part: 5 mg BI 425809
Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809.
|
SRD Part: 10 mg BI425809
Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809.
|
SRD Part: 25 mg BI 425809
Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809.
|
SRD Part: 50 mg BI 425809
Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809.
|
SRD Part: 100 mg BI 425809
Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
BA/FE Part: Tablet Without Food
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R).
|
BA/FE Part: Tablet With Food
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1).
|
BA/FE Part: Oral Solution Without Food
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
BA/FE Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))
|
9260 Nanomole*Hour/Liter
Geometric Coefficient of Variation 33.4
|
11900 Nanomole*Hour/Liter
Geometric Coefficient of Variation 21.8
|
11400 Nanomole*Hour/Liter
Geometric Coefficient of Variation 27.0
|
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|
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|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
Adverse Events
SRD Part: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SRD Part: 0.5 mg BI 425809
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SRD Part: 1 mg BI 425809
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SRD Part: 2 mg BI 425809
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SRD Part: 5 mg BI 425809
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SRD Part: 10 mg BI425809
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SRD Part: 25 mg BI 425809
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SRD Part: 50 mg BI 425809
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SRD Part: 100 mg BI 425809
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SRD Part: 150 mg BI 425809
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BA/FE Part: Tablet Without Food
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BA/FE Part: Tablet With Food
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BA/FE Part: Oral Solution Without Food
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SRD Part: Placebo
n=18 participants at risk
Participants received a single dose of oral solution of placebo matching BI 425809.
|
SRD Part: 0.5 mg BI 425809
n=6 participants at risk
Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809.
|
SRD Part: 1 mg BI 425809
n=6 participants at risk
Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809.
|
SRD Part: 2 mg BI 425809
n=6 participants at risk
Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809.
|
SRD Part: 5 mg BI 425809
n=6 participants at risk
Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809.
|
SRD Part: 10 mg BI425809
n=6 participants at risk
Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809.
|
SRD Part: 25 mg BI 425809
n=6 participants at risk
Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809.
|
SRD Part: 50 mg BI 425809
n=6 participants at risk
Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809.
|
SRD Part: 100 mg BI 425809
n=6 participants at risk
Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809.
|
SRD Part: 150 mg BI 425809
n=6 participants at risk
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809.
|
BA/FE Part: Tablet Without Food
n=11 participants at risk
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R).
|
BA/FE Part: Tablet With Food
n=11 participants at risk
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1).
|
BA/FE Part: Oral Solution Without Food
n=11 participants at risk
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
9.1%
1/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
9.1%
1/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
33.3%
2/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
50.0%
3/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
50.0%
3/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
50.0%
3/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
50.0%
3/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
27.3%
3/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
9.1%
1/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
18.2%
2/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
33.3%
2/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
33.3%
2/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Eye disorders
Chromatopsia
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Eye disorders
Photopsia
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
66.7%
4/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Eye disorders
Vision blurred
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
66.7%
4/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
33.3%
2/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
9.1%
1/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
9.1%
1/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
1/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
9.1%
1/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
33.3%
2/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
9.1%
1/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
9.1%
1/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
1/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
9.1%
1/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
General disorders
Catheter site pain
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
General disorders
Fatigue
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
33.3%
2/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
66.7%
4/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
9.1%
1/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
|
Investigations
Visual field tests abnormal
|
0.00%
0/18 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
16.7%
1/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/6 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
0.00%
0/11 • SRD Part: From the time of first drug administration until the end of study, up to 18 days for each intervention. BA/FE Part: From the time of first drug administration until the end of study, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER