Trial Outcomes & Findings for A Study in Healthy Japanese and Chinese Men to Test How Well Different Doses of BI 706321 Are Tolerated (NCT NCT05183360)
NCT ID: NCT05183360
Last Updated: 2025-09-23
Results Overview
The percentage of participants treated with investigational drug who experience such an event. Percentage of participants with treatment-emergent adverse events assessed as drug-related by the investigator are reported. Percentages are calculated using total number of participants per treatment as the denominator.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
From 1st drug administration on Day 1 till Day 19 + 16 days Residual Effect Period (REP), up to 35 days.
Results posted on
2025-09-23
Participant Flow
This was a randomized, placebo-controlled, double-blind trial conducted in two parts. Part I involved 48 healthy Japanese males who received BI 706321 as single and multiple rising doses. Part II was planned to involve healthy Chinese males receiving a single dose of BI 706321, but the trial was prematurely discontinued before starting Part II, and no participants were enrolled in Part II.
48 Japanese male participants who met all inclusion criteria and no exclusion criteria were enrolled in Part I of the trial. All received the trial medication and placebo as planned and completed the trial per protocol. Participants were free to withdraw at any time and were closely monitored. The trial was prematurely discontinued per protocol before Part II began.
Participant milestones
| Measure |
Placebo Matching BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.
|
2 mg BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.
|
5 mg BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.
|
8 mg BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.
|
10 mg BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
12
|
9
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Japanese and Chinese Men to Test How Well Different Doses of BI 706321 Are Tolerated
Baseline characteristics by cohort
| Measure |
Placebo Matching BI 706321 (Part I)
n=12 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.
|
2 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.
|
5 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.
|
8 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.
|
10 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.8 Years
STANDARD_DEVIATION 7.9 • n=93 Participants
|
31.9 Years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
29.4 Years
STANDARD_DEVIATION 7.6 • n=27 Participants
|
31.9 Years
STANDARD_DEVIATION 7.5 • n=483 Participants
|
32.3 Years
STANDARD_DEVIATION 6.5 • n=36 Participants
|
31.7 Years
STANDARD_DEVIATION 7.4 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
48 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
48 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
48 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From 1st drug administration on Day 1 till Day 19 + 16 days Residual Effect Period (REP), up to 35 days.Population: Treated set: all participants who were randomized and treated with at least one dose of the study drug.
The percentage of participants treated with investigational drug who experience such an event. Percentage of participants with treatment-emergent adverse events assessed as drug-related by the investigator are reported. Percentages are calculated using total number of participants per treatment as the denominator.
Outcome measures
| Measure |
Placebo Matching BI 706321 (Part I)
n=12 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.
|
2 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.
|
5 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.
|
8 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.
|
10 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Drug-related Adverse Events
|
8.3 Percentage (%) of participants
|
11.1 Percentage (%) of participants
|
44.4 Percentage (%) of participants
|
66.7 Percentage (%) of participants
|
88.9 Percentage (%) of participants
|
SECONDARY outcome
Timeframe: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
The area under the concentration-time curve of the BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUCR0-∞) after the first dose administration is reported.
Outcome measures
| Measure |
Placebo Matching BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.
|
2 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.
|
5 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.
|
8 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.
|
10 mg BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.
|
|---|---|---|---|---|---|
|
Single-Dose Part: Area Under the Concentration-time Curve of the BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUCR0-∞)
|
78.0 Hours*(nanomoles/L)
Geometric Coefficient of Variation 31.8
|
196 Hours*(nanomoles/L)
Geometric Coefficient of Variation 28.7
|
447 Hours*(nanomoles/L)
Geometric Coefficient of Variation 32.9
|
393 Hours*(nanomoles/L)
Geometric Coefficient of Variation 25.7
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
The maximum measured concentration of BI 706321 in plasma (Cmax) after the first dose administration is reported.
Outcome measures
| Measure |
Placebo Matching BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.
|
2 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.
|
5 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.
|
8 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.
|
10 mg BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.
|
|---|---|---|---|---|---|
|
Single-Dose Part: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)
|
3.00 Nanomoles per Liters
Geometric Coefficient of Variation 30.6
|
8.20 Nanomoles per Liters
Geometric Coefficient of Variation 47.9
|
18.4 Nanomoles per Liters
Geometric Coefficient of Variation 35.4
|
17.7 Nanomoles per Liters
Geometric Coefficient of Variation 36.4
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
The time from dosing to maximum measured concentration of BI 706321 in plasma after first drug administration is reported.
Outcome measures
| Measure |
Placebo Matching BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.
|
2 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.
|
5 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.
|
8 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.
|
10 mg BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.
|
|---|---|---|---|---|---|
|
Single-Dose Part: Time From Dosing to Maximum Measured Concentration of BI 706321 in Plasma
|
5.00 Hours
Interval 2.0 to 5.0
|
5.00 Hours
Interval 2.0 to 5.0
|
5.00 Hours
Interval 2.0 to 5.0
|
5.00 Hours
Interval 2.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 706321 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after single and multiple dose administration is reported.
Outcome measures
| Measure |
Placebo Matching BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.
|
2 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.
|
5 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.
|
8 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.
|
10 mg BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
|
144 Hours*(nanomoles/L)
Geometric Coefficient of Variation 44.8
|
297 Hours*(nanomoles/L)
Geometric Coefficient of Variation 21.9
|
764 Hours*(nanomoles/L)
Geometric Coefficient of Variation 19.3
|
641 Hours*(nanomoles/L)
Geometric Coefficient of Variation 23.0
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after single and multiple dose administration is reported
Outcome measures
| Measure |
Placebo Matching BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.
|
2 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.
|
5 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.
|
8 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.
|
10 mg BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.
|
|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
|
7.30 Nanomoles per Liters
Geometric Coefficient of Variation 55.4
|
20.0 Nanomoles per Liters
Geometric Coefficient of Variation 25.7
|
52.4 Nanomoles per Liters
Geometric Coefficient of Variation 11.1
|
43.3 Nanomoles per Liters
Geometric Coefficient of Variation 24.5
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Minimum concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) after single and multiple dose administration is reported.
Outcome measures
| Measure |
Placebo Matching BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.
|
2 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.
|
5 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.
|
8 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.
|
10 mg BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.
|
|---|---|---|---|---|---|
|
Minimum Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss)
|
3.47 Nanomoles per Liters
Geometric Coefficient of Variation 39.0
|
7.88 Nanomoles per Liters
Geometric Coefficient of Variation 31.9
|
20.8 Nanomoles per Liters
Geometric Coefficient of Variation 27.0
|
17.4 Nanomoles per Liters
Geometric Coefficient of Variation 25.1
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
The accumulation ratio based on Cₘₐₓ (Rᴀ,ᴄₘₐₓ,ₛₛ) shows how much the drug concentration increases at steady state compared to the first dose. It is calculated as a ratio of Cₘₐₓ at steady state (Cₘₐₓ,ₛₛ) and Cₘₐₓ after the first dose (Cₘₐₓ). Rᴀ,ᴄₘₐₓ,ₛₛ = Cₘₐₓₛₛ/Cₘₐₓ.
Outcome measures
| Measure |
Placebo Matching BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.
|
2 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.
|
5 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.
|
8 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.
|
10 mg BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.
|
|---|---|---|---|---|---|
|
Accumulation Ratio Based on Cₘₐₓ (Rᴀ,ᴄₘₐₓ,ₛₛ)
|
2.43 Ratio - no unit
Geometric Coefficient of Variation 34.5
|
2.44 Ratio - no unit
Geometric Coefficient of Variation 25.2
|
2.85 Ratio - no unit
Geometric Coefficient of Variation 36.2
|
2.44 Ratio - no unit
Geometric Coefficient of Variation 23.1
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.Population: Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
The accumulation ratio based on AUC₀-ₜ (Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ) shows how much the total drug exposure over a uniform dosing interval τ increases at steady state compared to the first dose. It is calculated as a ration of AUC₀-ₜ at steady state (AUC₀-ₜₛₛ) and AUC₀-ₜ after the first dose (AUC₀-ₜ). Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ = AUC₀-ₜₛₛ/AUC₀-ₜ.
Outcome measures
| Measure |
Placebo Matching BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.
|
2 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.
|
5 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.
|
8 mg BI 706321 (Part I)
n=9 Participants
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.
|
10 mg BI 706321 (Part I)
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.
|
|---|---|---|---|---|---|
|
Accumulation Ratio Based on AUC₀-ₜ (Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ)
|
3.03 Ratio - no unit
Geometric Coefficient of Variation 29.1
|
3.00 Ratio - no unit
Geometric Coefficient of Variation 23.2
|
3.52 Ratio - no unit
Geometric Coefficient of Variation 31.0
|
3.12 Ratio - no unit
Geometric Coefficient of Variation 18.9
|
—
|
Adverse Events
Placebo Matching BI 706321 (Part I)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
2 mg BI 706321 (Part I)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
5 mg BI 706321 (Part I)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
8 mg BI 706321 (Part I)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
10 mg BI 706321 (Part I)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Matching BI 706321 (Part I)
n=12 participants at risk
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.
|
2 mg BI 706321 (Part I)
n=9 participants at risk
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.
|
5 mg BI 706321 (Part I)
n=9 participants at risk
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.
|
8 mg BI 706321 (Part I)
n=9 participants at risk
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.
|
10 mg BI 706321 (Part I)
n=9 participants at risk
This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
4/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
22.2%
2/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
22.2%
2/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
|
General disorders
Fatigue
|
0.00%
0/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
22.2%
2/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
55.6%
5/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
77.8%
7/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
22.2%
2/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
22.2%
2/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
33.3%
3/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
22.2%
2/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
33.3%
3/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
22.2%
2/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
44.4%
4/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
44.4%
4/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
0.00%
0/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
11.1%
1/9 • Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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