Trial Outcomes & Findings for Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms (NCT NCT02865538)
NCT ID: NCT02865538
Last Updated: 2025-02-07
Results Overview
Cmax is the maximum observed plasma concentration of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
76 participants
Primary outcome timeframe
On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours)
Results posted on
2025-02-07
Participant Flow
The study was conducted between 01 August 2016 (first subject, screening visit) and 28 March 2017 (last subject, last visit).
Overall 316 subjects were screened, of them 240 were screening failure. 76 subjects were randomized and assigned to treatment. 18 subjects were randomized to placebo and 58 subjects to BAY3427080 (NT-814) arms. 2 subjects discontinued the study .
Participant milestones
| Measure |
Placebo Comparator
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
150 mg BAY3427080
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
300 mg of BAY3427080
300 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
15
|
15
|
13
|
|
Overall Study
COMPLETED
|
17
|
15
|
14
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Comparator
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
150 mg BAY3427080
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
300 mg of BAY3427080
300 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms
Baseline characteristics by cohort
| Measure |
Placebo Comparator
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
300 mg of BAY3427080
n=13 Participants
300 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.2 Years
STANDARD_DEVIATION 4.08 • n=5 Participants
|
55.9 Years
STANDARD_DEVIATION 5.57 • n=7 Participants
|
55.3 Years
STANDARD_DEVIATION 5.43 • n=5 Participants
|
56.7 Years
STANDARD_DEVIATION 4.37 • n=4 Participants
|
53.8 Years
STANDARD_DEVIATION 3.88 • n=21 Participants
|
55.4 Years
STANDARD_DEVIATION 4.67 • n=8 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
76 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
62 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Weight
|
73.25 kg
STANDARD_DEVIATION 10.11 • n=5 Participants
|
70.85 kg
STANDARD_DEVIATION 11.82 • n=7 Participants
|
73.47 kg
STANDARD_DEVIATION 14.93 • n=5 Participants
|
72.10 kg
STANDARD_DEVIATION 7.10 • n=4 Participants
|
72.73 kg
STANDARD_DEVIATION 12.05 • n=21 Participants
|
72.48 kg
STANDARD_DEVIATION 11.20 • n=8 Participants
|
PRIMARY outcome
Timeframe: On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours)Population: Participants who received placebo were not included in the PK population.
Cmax is the maximum observed plasma concentration of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.
Outcome measures
| Measure |
Placebo
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of BAY3427080
Day 1
|
—
|
502.62 ng/mL
Geometric Coefficient of Variation 90.19
|
731.69 ng/mL
Geometric Coefficient of Variation 110.58
|
911.48 ng/mL
Geometric Coefficient of Variation 148.28
|
1576.01 ng/mL
Geometric Coefficient of Variation 90.70
|
|
Maximum Observed Plasma Concentration (Cmax) of BAY3427080
Day 7
|
—
|
548.60 ng/mL
Geometric Coefficient of Variation 57.47
|
809.48 ng/mL
Geometric Coefficient of Variation 116.58
|
1173.50 ng/mL
Geometric Coefficient of Variation 95.14
|
2045.61 ng/mL
Geometric Coefficient of Variation 152.87
|
|
Maximum Observed Plasma Concentration (Cmax) of BAY3427080
Day 14
|
—
|
522.36 ng/mL
Geometric Coefficient of Variation 87.88
|
841.42 ng/mL
Geometric Coefficient of Variation 107.16
|
1188.19 ng/mL
Geometric Coefficient of Variation 131.20
|
2851.83 ng/mL
Geometric Coefficient of Variation 116.53
|
PRIMARY outcome
Timeframe: On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours)Population: Participants who received placebo were not included in the PK population.
Time of occurrence of Cmax.Time to reach maximum plasma concentration of BAY3427080 was presented. Blood samples for Tmax were taken within 30 minutes prior to dose administration.
Outcome measures
| Measure |
Placebo
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080
Day 1
|
—
|
1.360 hr
Geometric Coefficient of Variation 40.01
|
1.320 hr
Geometric Coefficient of Variation 38.79
|
1.521 hr
Geometric Coefficient of Variation 41.95
|
1.471 hr
Geometric Coefficient of Variation 63.05
|
|
Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080
Day 7
|
—
|
1.432 hr
Geometric Coefficient of Variation 39.25
|
1.623 hr
Geometric Coefficient of Variation 43.19
|
1.536 hr
Geometric Coefficient of Variation 40.08
|
1.754 hr
Geometric Coefficient of Variation 56.18
|
|
Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080
Day 14
|
—
|
1.265 hr
Geometric Coefficient of Variation 46.32
|
1.445 hr
Geometric Coefficient of Variation 56.71
|
1.296 hr
Geometric Coefficient of Variation 23.35
|
1.342 hr
Geometric Coefficient of Variation 33.46
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours)Population: Participants in PK population with available data are reported. Participants who received placebo were not included in the PK population.
AUC from time zero extrapolated to infinity of BAY3427080 was presented. AUC0-∞ was only estimated following the Day 1 dose.
Outcome measures
| Measure |
Placebo
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=7 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=2 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=3 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=5 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080
|
—
|
2018.68 hr*ng/mL
Geometric Coefficient of Variation 38.43
|
1545.58 hr*ng/mL
Geometric Coefficient of Variation 3.49
|
1151.87 hr*ng/mL
Geometric Coefficient of Variation 66.73
|
6249.52 hr*ng/mL
Geometric Coefficient of Variation 101.01
|
PRIMARY outcome
Timeframe: On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours)Population: Participants who received placebo were not included in the PK population.
Area under the concentration-time curve (AUC) from time zero to the time of the last quantifiable concentration of BAY3427080 was presented. Blood samples for (AUC0-τ) were taken within 30 minutes prior to dose administration.
Outcome measures
| Measure |
Placebo
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080
Day 1
|
—
|
1400.167 hr*ng/mL
Geometric Coefficient of Variation 67.87
|
2341.882 hr*ng/mL
Geometric Coefficient of Variation 71.19
|
3012.793 hr*ng/mL
Geometric Coefficient of Variation 97.74
|
6527.569 hr*ng/mL
Geometric Coefficient of Variation 70.50
|
|
Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080
Day 7
|
—
|
2506.97 hr*ng/mL
Geometric Coefficient of Variation 48.05
|
4472.76 hr*ng/mL
Geometric Coefficient of Variation 63.83
|
6202.894 hr*ng/mL
Geometric Coefficient of Variation 43.92
|
12859.660 hr*ng/mL
Geometric Coefficient of Variation 85.47
|
|
Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080
Day 14
|
—
|
2341.55 hr*ng/mL
Geometric Coefficient of Variation 64.73
|
3542.41 hr*ng/mL
Geometric Coefficient of Variation 86.34
|
5163.500 hr*ng/mL
Geometric Coefficient of Variation 88.71
|
14822.860 hr*ng/mL
Geometric Coefficient of Variation 99.68
|
PRIMARY outcome
Timeframe: On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours)Population: Participants in PK population with available data are reported. Participants who received placebo were not included in the PK population.
Terminal elimination half-life of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.
Outcome measures
| Measure |
Placebo
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=7 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=2 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=8 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=11 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t½) of BAY3427080
Day 1
|
—
|
2.409 hr
Geometric Coefficient of Variation 34.15
|
1.903 hr
Geometric Coefficient of Variation 11.98
|
3.965 hr
Geometric Coefficient of Variation 45.94
|
3.142 hr
Geometric Coefficient of Variation 18.92
|
|
Terminal Elimination Half-life (t½) of BAY3427080
Day 7
|
—
|
2.443 hr
Geometric Coefficient of Variation 9.33
|
3.303 hr
Geometric Coefficient of Variation 21.20
|
3.482 hr
Geometric Coefficient of Variation 22.57
|
2.271 hr
|
|
Terminal Elimination Half-life (t½) of BAY3427080
Day 14
|
—
|
2.698 hr
Geometric Coefficient of Variation 21.64
|
2.042 hr
|
21.593 hr
Geometric Coefficient of Variation 24.58
|
20.427 hr
Geometric Coefficient of Variation 22.85
|
PRIMARY outcome
Timeframe: On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours)Population: Participants who received placebo were not included in the PK population.
Apparent clearance of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.
Outcome measures
| Measure |
Placebo
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of BAY3427080
Day 1
|
—
|
24.769 L/hr
Geometric Coefficient of Variation 38.43
|
64.700 L/hr
Geometric Coefficient of Variation 3.49
|
130.223 L/hr
Geometric Coefficient of Variation 66.73
|
48.004 L/hr
Geometric Coefficient of Variation 101.01
|
|
Apparent Clearance (CL/F) of BAY3427080
Day 7
|
—
|
19.944 L/hr
Geometric Coefficient of Variation 48.05
|
22.358 L/hr
Geometric Coefficient of Variation 63.83
|
24.182 L/hr
Geometric Coefficient of Variation 43.92
|
23.329 L/hr
Geometric Coefficient of Variation 85.47
|
|
Apparent Clearance (CL/F) of BAY3427080
Day 14
|
—
|
21.353 L/hr
Geometric Coefficient of Variation 64.73
|
28.229 L/hr
Geometric Coefficient of Variation 86.34
|
29.050 L/hr
Geometric Coefficient of Variation 88.71
|
20.239 L/hr
Geometric Coefficient of Variation 99.68
|
PRIMARY outcome
Timeframe: At day 14A physician or appropriately qualified delegate conducted a full physical examination. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant).
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination.
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: At day 14Reported results are cardiovascular system-examination findings at day 14. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant).
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (day -1) and day 14Holter monitors were supplied by iCardiac Technologies. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14 and remained in place until 24-hour assessments were completed.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day 14)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Second Degree AV Block - Type I (Day 14)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Second Degree AV Block - Type II(Day 14)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Sinus Bradycardia (HR < 40 bpm)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm)(Day-1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day-1)
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day-1)
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Other arrhythmias (Day-1)
|
17 Participants
|
13 Participants
|
15 Participants
|
15 Participants
|
12 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Second Degree AV Block - Type I (Day-1)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Sinus Bradycardia (HR < 40 bpm)(Day-1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
SupraVentricular Tachycardia (lasting > 10 beats) (Day-1)
|
4 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
At least three monomorphic beats in a row (Day 14)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm) (Day 14)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day 14)
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Other arrhythmias (Day 14)
|
18 Participants
|
14 Participants
|
13 Participants
|
15 Participants
|
13 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Presence of NSVT (Non-Sustained Ventricular Tachycardia) episodes (Day 14)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
SupraVentricular Tachycardia (lasting > 10 beats (Day 14)
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline and day 14Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing)
Baseline
|
80.11 mmHg
Standard Deviation 4.702
|
76.07 mmHg
Standard Deviation 5.257
|
77.67 mmHg
Standard Deviation 11.462
|
78.93 mmHg
Standard Deviation 6.147
|
77.92 mmHg
Standard Deviation 9.768
|
|
Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing)
Day 14 Change from Baseline
|
1.11 mmHg
Standard Deviation 9.579
|
2.53 mmHg
Standard Deviation 5.540
|
-0.07 mmHg
Standard Deviation 12.137
|
0.93 mmHg
Standard Deviation 7.216
|
1.62 mmHg
Standard Deviation 9.097
|
PRIMARY outcome
Timeframe: Baseline and day 14Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting)
Baseline
|
77.72 mmHg
Standard Deviation 6.542
|
74.27 mmHg
Standard Deviation 6.239
|
77.20 mmHg
Standard Deviation 10.705
|
74.80 mmHg
Standard Deviation 6.774
|
74.15 mmHg
Standard Deviation 8.245
|
|
Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting)
Day 14 Change from Baseline
|
0.11 mmHg
Standard Deviation 9.292
|
-0.53 mmHg
Standard Deviation 6.906
|
-0.79 mmHg
Standard Deviation 9.736
|
2.73 mmHg
Standard Deviation 9.384
|
1.77 mmHg
Standard Deviation 6.366
|
PRIMARY outcome
Timeframe: Baseline and day 14Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing)
Baseline
|
117.83 mmHg
Standard Deviation 10.733
|
114.60 mmHg
Standard Deviation 8.675
|
121.33 mmHg
Standard Deviation 17.867
|
118.87 mmHg
Standard Deviation 11.513
|
114.77 mmHg
Standard Deviation 15.095
|
|
Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing)
Day 14 Change from Baseline
|
5.11 mmHg
Standard Deviation 11.483
|
3.80 mmHg
Standard Deviation 13.311
|
-4.43 mmHg
Standard Deviation 18.744
|
0.33 mmHg
Standard Deviation 12.234
|
5.62 mmHg
Standard Deviation 16.536
|
PRIMARY outcome
Timeframe: Baseline and day 14Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting)
Baseline
|
116.39 mmHg
Standard Deviation 11.304
|
113.80 mmHg
Standard Deviation 9.405
|
119.07 mmHg
Standard Deviation 15.931
|
117.20 mmHg
Standard Deviation 10.638
|
114.15 mmHg
Standard Deviation 14.288
|
|
Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting)
Day 14 Change from Baseline
|
4.17 mmHg
Standard Deviation 11.868
|
0.20 mmHg
Standard Deviation 10.359
|
-2.79 mmHg
Standard Deviation 16.470
|
2.47 mmHg
Standard Deviation 16.890
|
5.62 mmHg
Standard Deviation 12.672
|
PRIMARY outcome
Timeframe: Baseline and day 14Pulse rate was measured just prior to dosing (approx. 30 mins).
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 in Vital Signs: Pulse Rate
Baseline
|
69.89 beats/min
Standard Deviation 8.629
|
66.00 beats/min
Standard Deviation 6.358
|
69.20 beats/min
Standard Deviation 9.966
|
68.40 beats/min
Standard Deviation 4.611
|
72.62 beats/min
Standard Deviation 7.136
|
|
Change From Baseline at Day 14 in Vital Signs: Pulse Rate
Day 14 Change from Baseline
|
1.06 beats/min
Standard Deviation 8.271
|
-2.00 beats/min
Standard Deviation 8.027
|
0.14 beats/min
Standard Deviation 7.263
|
0.27 beats/min
Standard Deviation 8.388
|
-11.00 beats/min
Standard Deviation 9.618
|
PRIMARY outcome
Timeframe: Baseline and day 14Respiratory rate was measured just prior to dosing (approx. 30 mins).
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 in Vital Signs: Respiratory Rate
Baseline
|
15.39 breaths/min
Standard Deviation 1.378
|
15.47 breaths/min
Standard Deviation 1.727
|
15.73 breaths/min
Standard Deviation 1.624
|
15.60 breaths/min
Standard Deviation 1.502
|
15.85 breaths/min
Standard Deviation 1.573
|
|
Change From Baseline at Day 14 in Vital Signs: Respiratory Rate
Day 14 Change from Baseline
|
-0.11 breaths/min
Standard Deviation 2.220
|
-0.40 breaths/min
Standard Deviation 2.197
|
0.07 breaths/min
Standard Deviation 1.940
|
-0.43 breaths/min
Standard Deviation 2.065
|
-1.33 breaths/min
Standard Deviation 1.923
|
PRIMARY outcome
Timeframe: Baseline and day 14Oxygen Saturation was measured just prior to dosing (approx. 30 mins).
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation
Baseline
|
98.50 Percentage of Oxygen satuartion
Standard Deviation 1.098
|
98.40 Percentage of Oxygen satuartion
Standard Deviation 1.404
|
97.87 Percentage of Oxygen satuartion
Standard Deviation 1.727
|
97.67 Percentage of Oxygen satuartion
Standard Deviation 1.496
|
97.31 Percentage of Oxygen satuartion
Standard Deviation 1.251
|
|
Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation
Day 14 Change from Baseline
|
-0.61 Percentage of Oxygen satuartion
Standard Deviation 1.539
|
-0.73 Percentage of Oxygen satuartion
Standard Deviation 1.486
|
0.29 Percentage of Oxygen satuartion
Standard Deviation 2.091
|
0.20 Percentage of Oxygen satuartion
Standard Deviation 1.424
|
0.38 Percentage of Oxygen satuartion
Standard Deviation 1.193
|
PRIMARY outcome
Timeframe: Baseline and day 14Temperature was measured just prior to dosing (approx. 30 mins).
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature
Baseline
|
36.77 Degree Celius
Standard Deviation 0.190
|
36.65 Degree Celius
Standard Deviation 0.155
|
36.79 Degree Celius
Standard Deviation 0.162
|
36.71 Degree Celius
Standard Deviation 0.168
|
36.77 Degree Celius
Standard Deviation 0.361
|
|
Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature
Day 14 Change from Baseline
|
-0.04 Degree Celius
Standard Deviation 0.243
|
0.06 Degree Celius
Standard Deviation 0.172
|
-0.09 Degree Celius
Standard Deviation 0.264
|
-0.01 Degree Celius
Standard Deviation 0.239
|
-0.05 Degree Celius
Standard Deviation 0.458
|
PRIMARY outcome
Timeframe: Baseline and day 14Weight was measured just prior to dosing (approx. 30 mins).
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 in Vital Signs: Weight
Day 14 Change from Baseline
|
0.36 Kilograms
Standard Deviation 1.034
|
0.51 Kilograms
Standard Deviation 0.983
|
0.24 Kilograms
Standard Deviation 0.916
|
0.15 Kilograms
Standard Deviation 0.926
|
0.01 Kilograms
Standard Deviation 0.704
|
|
Change From Baseline at Day 14 in Vital Signs: Weight
Baseline
|
73.25 Kilograms
Standard Deviation 10.115
|
70.85 Kilograms
Standard Deviation 11.821
|
73.47 Kilograms
Standard Deviation 14.934
|
72.10 Kilograms
Standard Deviation 7.104
|
72.73 Kilograms
Standard Deviation 12.047
|
PRIMARY outcome
Timeframe: Baseline and day 15Population: Participants with available data reported.
Blood samples for the assessment of ACTH and Estradiol were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol.
Baseline (ADTH)
|
5.34 pmol/L
Standard Deviation 3.402
|
4.17 pmol/L
Standard Deviation 1.991
|
3.87 pmol/L
Standard Deviation 2.361
|
3.55 pmol/L
Standard Deviation 2.360
|
3.27 pmol/L
Standard Deviation 2.011
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol.
Day 15 Change from Baseline (ADTH)
|
-0.49 pmol/L
Standard Deviation 3.333
|
-0.68 pmol/L
Standard Deviation 2.035
|
0.84 pmol/L
Standard Deviation 1.914
|
1.04 pmol/L
Standard Deviation 3.059
|
1.67 pmol/L
Standard Deviation 3.059
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol.
Baseline (Estradiol)
|
57.33 pmol/L
Standard Deviation 43.236
|
59.49 pmol/L
Standard Deviation 40.129
|
35.02 pmol/L
Standard Deviation 25.556
|
43.83 pmol/L
Standard Deviation 31.270
|
62.42 pmol/L
Standard Deviation 42.589
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol.
Day 15 Change from Baseline (Estradiol)
|
22.43 pmol/L
Standard Deviation 141.618
|
13.21 pmol/L
Standard Deviation 80.704
|
0.53 pmol/L
Standard Deviation 3.172
|
1.96 pmol/L
Standard Deviation 12.394
|
-9.02 pmol/L
Standard Deviation 87.480
|
PRIMARY outcome
Timeframe: Baseline and day 15Blood samples for the assessment of Follicle Stimulating were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone
Baseline
|
76.01 IU/L
Standard Deviation 23.122
|
100.87 IU/L
Standard Deviation 36.813
|
77.78 IU/L
Standard Deviation 20.132
|
88.77 IU/L
Standard Deviation 42.251
|
70.59 IU/L
Standard Deviation 17.046
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone
Day 15 Change from Baseline
|
5.98 IU/L
Standard Deviation 13.072
|
-2.29 IU/L
Standard Deviation 20.948
|
4.09 IU/L
Standard Deviation 8.353
|
6.73 IU/L
Standard Deviation 6.904
|
8.92 IU/L
Standard Deviation 13.409
|
PRIMARY outcome
Timeframe: Baseline and day 15Population: Participants in PK analysis set with evaluable data for this outcome measure presented.
Blood samples for the assessment of Triiodothyronine were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake
Baseline
|
32.300 Percentage of T Uptake
Standard Deviation 3.5623
|
30.800 Percentage of T Uptake
Standard Deviation 2.4712
|
30.838 Percentage of T Uptake
Standard Deviation 1.7968
|
30.671 Percentage of T Uptake
Standard Deviation 1.3060
|
—
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake
Day 15 Change from Baseline
|
-0.720 Percentage of T Uptake
Standard Deviation 0.7662
|
-0.700 Percentage of T Uptake
Standard Deviation 0.2944
|
0.143 Percentage of T Uptake
Standard Deviation 0.7115
|
0.443 Percentage of T Uptake
Standard Deviation 1.0130
|
—
|
PRIMARY outcome
Timeframe: Baseline and day 15Blood samples for the assessment of Thyrotropin were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin
Day 15 Change from Baseline
|
-0.959 mIU/L
Standard Deviation 1.3501
|
-0.571 mIU/L
Standard Deviation 0.8148
|
-0.648 mIU/L
Standard Deviation 0.5903
|
-0.823 mIU/L
Standard Deviation 1.0604
|
-0.616 mIU/L
Standard Deviation 1.1375
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin
Baseline
|
2.658 mIU/L
Standard Deviation 1.7584
|
1.800 mIU/L
Standard Deviation 0.9830
|
2.451 mIU/L
Standard Deviation 1.4811
|
2.785 mIU/L
Standard Deviation 1.1449
|
2.330 mIU/L
Standard Deviation 1.2658
|
PRIMARY outcome
Timeframe: Baseline and day 15Population: Participants with available data reported.
Blood samples for the assessment of Cortisol, Testosterone, Thyroxine and Triiodothyronine were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine
Baseline (Cortisol)
|
348.60 nmol/L
Standard Deviation 156.496
|
337.16 nmol/L
Standard Deviation 177.507
|
345.91 nmol/L
Standard Deviation 173.302
|
251.66 nmol/L
Standard Deviation 144.743
|
230.42 nmol/L
Standard Deviation 74.560
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine
Day 15 Change from Baseline (Cortisol)
|
15.94 nmol/L
Standard Deviation 193.564
|
-23.32 nmol/L
Standard Deviation 172.685
|
68.05 nmol/L
Standard Deviation 170.121
|
92.02 nmol/L
Standard Deviation 159.464
|
127.20 nmol/L
Standard Deviation 208.452
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine
Baseline (Testosterone)
|
0.744 nmol/L
Standard Deviation 0.3850
|
0.666 nmol/L
Standard Deviation 0.6230
|
0.517 nmol/L
Standard Deviation 0.2317
|
0.433 nmol/L
Standard Deviation 0.2961
|
0.611 nmol/L
Standard Deviation 0.4271
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine
Baseline(Thyroxine)
|
95.44 nmol/L
Standard Deviation 14.576
|
95.66 nmol/L
Standard Deviation 15.203
|
96.11 nmol/L
Standard Deviation 14.645
|
86.41 nmol/L
Standard Deviation 16.116
|
94.16 nmol/L
Standard Deviation 22.180
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine
Day 15 Change from Baseline(Thyroxine)
|
-3.78 nmol/L
Standard Deviation 14.771
|
-1.28 nmol/L
Standard Deviation 8.127
|
-10.67 nmol/L
Standard Deviation 26.324
|
6.53 nmol/L
Standard Deviation 9.546
|
0.88 nmol/L
Standard Deviation 13.720
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine
Baseline(Triiodothyronine)
|
1.865 nmol/L
Standard Deviation 0.14131
|
2.060 nmol/L
Standard Deviation 0.3174
|
1.980 nmol/L
Standard Deviation 0.2916
|
1.776 nmol/L
Standard Deviation 0.4510
|
2.163 nmol/L
Standard Deviation 0.6008
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine
Day 15 Change from Baseline (Triiodothyronine)
|
-0.190 nmol/L
Standard Deviation 0.3171
|
-0.141 nmol/L
Standard Deviation 0.2742
|
-0.407 nmol/L
Standard Deviation 0.2180
|
-0.148 nmol/L
Standard Deviation 0.1883
|
-0.416 nmol/L
Standard Deviation 0.5359
|
|
Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine
Day 15 Change from Baseline (Testosterone)
|
0.057 nmol/L
Standard Deviation 0.3567
|
0.024 nmol/L
Standard Deviation 0.2578
|
0.696 nmol/L
Standard Deviation 0.3367
|
0.480 nmol/L
Standard Deviation 0.4589
|
0.524 nmol/L
Standard Deviation 0.2905
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Cholesterol, Triglycerides,high-density lipoprotein (HDL)Cholesterol and low-density lipoprotein (LDL) Cholesterol were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol.
Day 14 Change from Baseline (Cholesterol)
|
0.088 mmol/L
Standard Deviation 0.8629
|
-0.061 mmol/L
Standard Deviation 0.4761
|
-0.205 mmol/L
Standard Deviation 0.8981
|
-0.185 mmol/L
Standard Deviation 0.6386
|
-0.321 mmol/L
Standard Deviation 0.6790
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol.
Baseline (Triglycerides)
|
1.163 mmol/L
Standard Deviation 0.5796
|
1.185 mmol/L
Standard Deviation 0.5036
|
1.131 mmol/L
Standard Deviation 0.5889
|
1.329 mmol/L
Standard Deviation 0.6245
|
1.353 mmol/L
Standard Deviation 0.5540
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol.
Day 14 Change from Baseline( HDL Cholesterol)
|
-0.167 mmol/L
Standard Deviation 0.2824
|
-0.219 mmol/L
Standard Deviation 0.2015
|
-0.056 mmol/L
Standard Deviation 0.2559
|
-0.147 mmol/L
Standard Deviation 0.1546
|
-0.158 mmol/L
Standard Deviation 0.3132
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol.
Baseline( LDL Cholesterol)
|
3.226 mmol/L
Standard Deviation 1.0485
|
3.125 mmol/L
Standard Deviation 0.8436
|
3.172 mmol/L
Standard Deviation 0.7654
|
3.625 mmol/L
Standard Deviation 0.7188
|
3.552 mmol/L
Standard Deviation 1.1088
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol.
Day 14 Change from Baseline ( LDL Cholesterol)
|
-0.013 mmol/L
Standard Deviation 0.3926
|
0.184 mmol/L
Standard Deviation 0.2958
|
-0.119 mmol/L
Standard Deviation 0.6747
|
-0.038 mmol/L
Standard Deviation 0.6490
|
-0.053 mmol/L
Standard Deviation 0.5944
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol.
Baseline (Cholesterol)
|
5.434 mmol/L
Standard Deviation 1.0223
|
5.471 mmol/L
Standard Deviation 0.6592
|
5.391 mmol/L
Standard Deviation 0.7346
|
5.804 mmol/L
Standard Deviation 0.6462
|
5.393 mmol/L
Standard Deviation 0.9008
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol.
Day 14 Change from Baseline (Triglycerides)
|
0.048 mmol/L
Standard Deviation 0.4936
|
-0.071 mmol/L
Standard Deviation 0.4725
|
-0.116 mmol/L
Standard Deviation 0.5247
|
-0.029 mmol/L
Standard Deviation 0.4178
|
-0.172 mmol/L
Standard Deviation 0.5633
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol.
Baseline(HDL Cholesterol)
|
1.717 mmol/L
Standard Deviation 0.4525
|
1.879 mmol/L
Standard Deviation 0.4052
|
1.7444 mmol/L
Standard Deviation 0.6563
|
1.768 mmol/L
Standard Deviation 0.4716
|
1.449 mmol/L
Standard Deviation 0.2752
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Neutrophils/Leukocytes, Lymphocytes /Leukocytes, Monocytes/Leukocytes, Eosinophils/Leukocytes, Basophils/Leukocytes and Immature Granulocytes/ Leukocytes were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Baseline (Neutrophils/ Leukocytes)
|
56.53 Percentage of total white blood cells
Standard Deviation 7.700
|
53.31 Percentage of total white blood cells
Standard Deviation 4.994
|
55.65 Percentage of total white blood cells
Standard Deviation 8.318
|
54.78 Percentage of total white blood cells
Standard Deviation 8.610
|
50.92 Percentage of total white blood cells
Standard Deviation 10.316
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Day 14 Change from Baseline (Neutrophils/ Leukocytes)
|
-0.29 Percentage of total white blood cells
Standard Deviation 7.788
|
2.41 Percentage of total white blood cells
Standard Deviation 6.119
|
-0.50 Percentage of total white blood cells
Standard Deviation 5.047
|
-0.98 Percentage of total white blood cells
Standard Deviation 7.116
|
-2.69 Percentage of total white blood cells
Standard Deviation 10.614
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Baseline (Lymphocytes/ Leukocytes)
|
32.40 Percentage of total white blood cells
Standard Deviation 7.098
|
35.57 Percentage of total white blood cells
Standard Deviation 5.439
|
33.33 Percentage of total white blood cells
Standard Deviation 8.024
|
34.33 Percentage of total white blood cells
Standard Deviation 7.444
|
36.78 Percentage of total white blood cells
Standard Deviation 10.446
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Day 14 Change from Baseline( Monocytes/ Leukocytes)
|
0.22 Percentage of total white blood cells
Standard Deviation 1.947
|
-0.15 Percentage of total white blood cells
Standard Deviation 1.751
|
0.65 Percentage of total white blood cells
Standard Deviation 1.291
|
0.05 Percentage of total white blood cells
Standard Deviation 2.758
|
0.22 Percentage of total white blood cells
Standard Deviation 3.850
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Baseline( Immature Granulocytes/ Leukocytes)
|
0.15 Percentage of total white blood cells
Standard Deviation 0.084
|
0.25 Percentage of total white blood cells
Standard Deviation 0.100
|
0.20 Percentage of total white blood cells
Standard Deviation 0.151
|
0.13 Percentage of total white blood cells
Standard Deviation 0.111
|
0.15 Percentage of total white blood cells
Standard Deviation 0.084
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Day 14 Change from Baseline( Immature Granulocytes/ Leukocytes)
|
0.03 Percentage of total white blood cells
Standard Deviation 0.082
|
-0.05 Percentage of total white blood cells
Standard Deviation 0.100
|
0.09 Percentage of total white blood cells
Standard Deviation 0.157
|
0.00 Percentage of total white blood cells
Standard Deviation 0.183
|
0.03 Percentage of total white blood cells
Standard Deviation 0.137
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Day 14 Change from Baseline(Lymphocytes / Leukocytes)
|
0.18 Percentage of total white blood cells
Standard Deviation 5.791
|
-2.46 Percentage of total white blood cells
Standard Deviation 5.667
|
-0.11 Percentage of total white blood cells
Standard Deviation 4.763
|
0.59 Percentage of total white blood cells
Standard Deviation 5.835
|
2.75 Percentage of total white blood cells
Standard Deviation 10.926
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Baseline ( Monocytes / Leukocytes )
|
7.58 Percentage of total white blood cells
Standard Deviation 1.592
|
7.47 Percentage of total white blood cells
Standard Deviation 1.379
|
7.62 Percentage of total white blood cells
Standard Deviation 1.591
|
7.71 Percentage of total white blood cells
Standard Deviation 1.762
|
8.62 Percentage of total white blood cells
Standard Deviation 3.276
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Baseline ( Eosinophils/ Leukocytes)
|
2.83 Percentage of total white blood cells
Standard Deviation 2.433
|
3.04 Percentage of total white blood cells
Standard Deviation 3.352
|
2.64 Percentage of total white blood cells
Standard Deviation 1.422
|
2.61 Percentage of total white blood cells
Standard Deviation 1.170
|
3.05 Percentage of total white blood cells
Standard Deviation 1.979
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Day 14 Change from Baseline(Eosinophils/ Leukocytes)
|
0.02 Percentage of total white blood cells
Standard Deviation 1.316
|
0.29 Percentage of total white blood cells
Standard Deviation 0.961
|
0.06 Percentage of total white blood cells
Standard Deviation 0.794
|
0.33 Percentage of total white blood cells
Standard Deviation 0.538
|
-0.24 Percentage of total white blood cells
Standard Deviation 1.189
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Baseline(Basophils/ Leukocytes)
|
0.61 Percentage of total white blood cells
Standard Deviation 0.263
|
0.55 Percentage of total white blood cells
Standard Deviation 0.177
|
0.66 Percentage of total white blood cells
Standard Deviation 0.295
|
0.51 Percentage of total white blood cells
Standard Deviation 0.223
|
0.56 Percentage of total white blood cells
Standard Deviation 0.373
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Day 14 Change from Baseline (Basophils/ Leukocytes)
|
-0.13 Percentage of total white blood cells
Standard Deviation 0.181
|
-0.07 Percentage of total white blood cells
Standard Deviation 0.111
|
-0.14 Percentage of total white blood cells
Standard Deviation 0.122
|
0.01 Percentage of total white blood cells
Standard Deviation 0.209
|
-0.05 Percentage of total white blood cells
Standard Deviation 0.307
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets were collected upon participant's admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Day 14 Change from Baseline (Neutrophils )
|
-0.374 10^9*cells/L
Standard Deviation 1.1794
|
0.072 10^9*cells/L
Standard Deviation 0.7422
|
-0.246 10^9*cells/L
Standard Deviation 0.5487
|
-0.539 10^9*cells/L
Standard Deviation 0.9017
|
-0.186 10^9*cells/L
Standard Deviation 1.4444
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Baseline ( Eosinophils)
|
0.202 10^9*cells/L
Standard Deviation 0.2325
|
0.185 10^9*cells/L
Standard Deviation 0.1814
|
0.177 10^9*cells/L
Standard Deviation 0.1090
|
0.177 10^9*cells/L
Standard Deviation 0.0954
|
0.208 10^9*cells/L
Standard Deviation 0.1592
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Baseline( Immature Granulocytes)
|
0.00 10^9*cells/L
Standard Deviation 0.00
|
0.00 10^9*cells/L
Standard Deviation 0.00
|
0.00 10^9*cells/L
Standard Deviation 0.00
|
0.00 10^9*cells/L
Standard Deviation 0.00
|
0.00 10^9*cells/L
Standard Deviation 0.00
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Baseline (Platelets )
|
263.4 10^9*cells/L
Standard Deviation 59.66
|
249.1 10^9*cells/L
Standard Deviation 61.67
|
269.8 10^9*cells/L
Standard Deviation 61.40
|
261.9 10^9*cells/L
Standard Deviation 46.91
|
258.2 10^9*cells/L
Standard Deviation 52.57
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Baseline( Leukocytes)
|
6.73 10^9*cells/L
Standard Deviation 1.372
|
6.54 10^9*cells/L
Standard Deviation 1.613
|
6.75 10^9*cells/L
Standard Deviation 1.245
|
6.78 10^9*cells/L
Standard Deviation 1.307
|
6.60 10^9*cells/L
Standard Deviation 1.896
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Day 14 Change from Baseline( Leukocytes)
|
-0.60 10^9*cells/L
Standard Deviation 1.299
|
-0.27 10^9*cells/L
Standard Deviation 1.134
|
-0.34 10^9*cells/L
Standard Deviation 0.686
|
-0.80 10^9*cells/L
Standard Deviation 1.011
|
-0.06 10^9*cells/L
Standard Deviation 1.650
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Baseline (Neutrophils)
|
3.847 10^9*cells/L
Standard Deviation 1.0899
|
3.493 10^9*cells/L
Standard Deviation 0.9737
|
3.779 10^9*cells/L
Standard Deviation 0.9332
|
3.745 10^9*cells/L
Standard Deviation 0.9686
|
3.394 10^9*cells/L
Standard Deviation 1.3264
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Baseline (Lymphocytes)
|
2.148 10^9*cells/L
Standard Deviation 0.4905
|
2.341 10^9*cells/L
Standard Deviation 0.7009
|
2.242 10^9*cells/L
Standard Deviation 0.6199
|
2.320 10^9*cells/L
Standard Deviation 0.6467
|
2.429 10^9*cells/L
Standard Deviation 0.9032
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Day 14 Change from Baseline (Lymphocytes)
|
-0.172 10^9*cells/L
Standard Deviation 0.2900
|
-0.301 10^9*cells/L
Standard Deviation 0.5336
|
-0.107 10^9*cells/L
Standard Deviation 0.3652
|
-0.237 10^9*cells/L
Standard Deviation 0.3901
|
0.142 10^9*cells/L
Standard Deviation 0.6749
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Baseline ( Monocytes)
|
0.499 10^9*cells/L
Standard Deviation 0.0984
|
0.479 10^9*cells/L
Standard Deviation 0.1051
|
0.505 10^9*cells/L
Standard Deviation 0.0990
|
0.524 10^9*cells/L
Standard Deviation 0.1410
|
0.534 10^9*cells/L
Standard Deviation 0.1552
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Day 14 Change from Baseline( Monocytes)
|
-0.033 10^9*cells/L
Standard Deviation 0.1117
|
-0.030 10^9*cells/L
Standard Deviation 0.1324
|
0.019 10^9*cells/L
Standard Deviation 0.0895
|
-0.057 10^9*cells/L
Standard Deviation 0.1941
|
0.002 10^9*cells/L
Standard Deviation 0.1643
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Day 14 Change from Baseline(Eosinophils)
|
-0.017 10^9*cells/L
Standard Deviation 0.0995
|
0.021 10^9*cells/L
Standard Deviation 0.0719
|
-0.006 10^9*cells/L
Standard Deviation 0.0549
|
0.005 10^9*cells/L
Standard Deviation 0.0436
|
-0.028 10^9*cells/L
Standard Deviation 0.1155
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Baseline(Basophils)
|
0.041 10^9*cells/L
Standard Deviation 0.0305
|
0.031 10^9*cells/L
Standard Deviation 0.0264
|
0.028 10^9*cells/L
Standard Deviation 0.0321
|
0.027 10^9*cells/L
Standard Deviation 0.0301
|
0.030 10^9*cells/L
Standard Deviation 0.327
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Day 14 Change from Baseline(Basophils)
|
-0.008 10^9*cells/L
Standard Deviation 0.0148
|
-0.007 10^9*cells/L
Standard Deviation 0.0090
|
-0.001 10^9*cells/L
Standard Deviation 0.0305
|
-0.010 10^9*cells/L
Standard Deviation 0.0259
|
-0.002 10^9*cells/L
Standard Deviation 0.0060
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Day 14 Change from Baseline( Immature Granulocytes)
|
0.00 10^9*cells/L
Standard Deviation 0.00
|
0.00 10^9*cells/L
Standard Deviation 0.00
|
0.00 10^9*cells/L
Standard Deviation 0.00
|
0.00 10^9*cells/L
Standard Deviation 0.00
|
0.00 10^9*cells/L
Standard Deviation 0.00
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Day 14 Change from Baseline(Platelets )
|
8.1 10^9*cells/L
Standard Deviation 17.77
|
4.5 10^9*cells/L
Standard Deviation 33.83
|
13.5 10^9*cells/L
Standard Deviation 29.67
|
21.6 10^9*cells/L
Standard Deviation 24.58
|
20.8 10^9*cells/L
Standard Deviation 74.35
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin (HB)concentration were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration
Baseline (Erythrocytes Mean Corpuscular HB concentration )
|
328.5 g/L
Standard Deviation 10.30
|
335.2 g/L
Standard Deviation 9.42
|
329.0 g/L
Standard Deviation 10.22
|
328.2 g/L
Standard Deviation 7.51
|
326.8 g/L
Standard Deviation 10.27
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration
Baseline (Hemoglobin)
|
128.9 g/L
Standard Deviation 8.53
|
132.4 g/L
Standard Deviation 10.64
|
128.7 g/L
Standard Deviation 7.82
|
127.7 g/L
Standard Deviation 8.60
|
132.2 g/L
Standard Deviation 12.60
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration
Day 14 Change from Baseline (Hemoglobin)
|
-11.8 g/L
Standard Deviation 4.99
|
-9.0 g/L
Standard Deviation 7.14
|
-14.6 g/L
Standard Deviation 5.98
|
-13.9 g/L
Standard Deviation 4.66
|
-12.1 g/L
Standard Deviation 6.58
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration
Day 14 Change from Baseline (Erythrocytes Mean Corpuscular HB concentration)
|
-0.4 g/L
Standard Deviation 5.21
|
-2.5 g/L
Standard Deviation 2.34
|
-2.3 g/L
Standard Deviation 6.94
|
-0.8 g/L
Standard Deviation 3.41
|
3.2 g/L
Standard Deviation 4.62
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Erythrocytes were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes
Baseline
|
4.467 10^12*cells/L
Standard Deviation 0.2503
|
4.525 10^12*cells/L
Standard Deviation 0.2212
|
4.459 10^12*cells/L
Standard Deviation 0.2962
|
4.365 10^12*cells/L
Standard Deviation 0.3678
|
4.518 10^12*cells/L
Standard Deviation 0.2368
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes
Day 14 Change from Baseline
|
-0.421 10^12*cells/L
Standard Deviation 0.1750
|
-0.301 10^12*cells/L
Standard Deviation 0.2694
|
-0.511 10^12*cells/L
Standard Deviation 0.2111
|
-0.485 10^12*cells/L
Standard Deviation 0.1903
|
-0.425 10^12*cells/L
Standard Deviation 0.2297
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume.
Baseline (Erythrocytes Mean Corpuscular Volume )
|
87.87 fL
Standard Deviation 5.707
|
87.69 fL
Standard Deviation 3.890
|
87.71 fL
Standard Deviation 4.717
|
89.42 fL
Standard Deviation 6.744
|
88.63 fL
Standard Deviation 3.150
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume.
Day 14 Change from Baseline (Erythrocytes Mean Corpuscular Volume )
|
0.44 fL
Standard Deviation 1.155
|
0.11 fL
Standard Deviation 0.799
|
0.47 fL
Standard Deviation 0.967
|
0.49 fL
Standard Deviation 1,691
|
-0.27 fL
Standard Deviation 0.659
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume.
Baseline (Mean Platelet Volume)
|
9.79 fL
Standard Deviation 0.809
|
9.91 fL
Standard Deviation 1.608
|
10.22 fL
Standard Deviation 1.565
|
10.19 fL
Standard Deviation 1.005
|
10.05 fL
Standard Deviation 1.179
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume.
Day 14 Change from Baseline (Mean Platelet Volume)
|
-0.14 fL
Standard Deviation 0.448
|
0.08 fL
Standard Deviation 0.412
|
-0.24 fL
Standard Deviation 0.220
|
-0.37 fL
Standard Deviation 0.403
|
-0.06 fL
Standard Deviation 0.216
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Erythrocytes Mean Corpuscular Hemoglobin were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin
Day 14 Change from Baseline
|
0.09 pg
Standard Deviation 0.494
|
-0.19 pg
Standard Deviation 0.263
|
0.03 pg
Standard Deviation 0.486
|
0.15 pg
Standard Deviation 0.532
|
0.17 pg
Standard Deviation 0.317
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin
Baseline
|
28.89 pg
Standard Deviation 2.517
|
29.50 pg
Standard Deviation 1.803
|
28.79 pg
Standard Deviation 2.217
|
29.39 pg
Standard Deviation 2.511
|
28.89 pg
Standard Deviation 1.759
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Erythrocytes Distribution Width were collected upon participants admission to the unit. Erythrocytes distribution width (in percentage) = 1 SD of Erythrocyte volume/MCV x 100%
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width.
Baseline
|
27.81 Percentage of Erythrocyte volume
Standard Deviation 15.478
|
25.52 Percentage of Erythrocyte volume
Standard Deviation 15.413
|
35.82 Percentage of Erythrocyte volume
Standard Deviation 16.476
|
30.59 Percentage of Erythrocyte volume
Standard Deviation 16.089
|
31.48 Percentage of Erythrocyte volume
Standard Deviation 17.013
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width.
Day 14 Change from Baseline
|
-0.15 Percentage of Erythrocyte volume
Standard Deviation 0.916
|
0.49 Percentage of Erythrocyte volume
Standard Deviation 0.863
|
-0.05 Percentage of Erythrocyte volume
Standard Deviation 1.878
|
-0.61 Percentage of Erythrocyte volume
Standard Deviation 0.696
|
-0.68 Percentage of Erythrocyte volume
Standard Deviation 0.778
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Hematocrit were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit.
Baseline
|
39.18 Volume percentage
Standard Deviation 1.976
|
39.63 Volume percentage
Standard Deviation 2.461
|
38.99 Volume percentage
Standard Deviation 1.788
|
38.85 Volume percentage
Standard Deviation 1.990
|
40.02 Volume percentage
Standard Deviation 2.646
|
|
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit.
Day 14 Change from Baseline
|
-3.51 Volume percentage
Standard Deviation 1.307
|
-2.45 Volume percentage
Standard Deviation 2.106
|
-4.20 Volume percentage
Standard Deviation 1.877
|
-4.13 Volume percentage
Standard Deviation 1.431
|
-3.86 Volume percentage
Standard Deviation 2.163
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Protein and Albumin were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin.
Day 14 Change from Baseline(Protein)
|
-4.0 g/L
Standard Deviation 3.11
|
-2.5 g/L
Standard Deviation 4.39
|
-6.9 g/L
Standard Deviation 4.89
|
-4.1 g/L
Standard Deviation 2.64
|
-2.5 g/L
Standard Deviation 3.10
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin.
Day 14 Change from Baseline (Albumin)
|
-0.6 g/L
Standard Deviation 6.42
|
-2.5 g/L
Standard Deviation 2.42
|
-3.2 g/L
Standard Deviation 2.08
|
0.3 g/L
Standard Deviation 2.05
|
-1.8 g/L
Standard Deviation 2.44
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin.
Baseline (Protein)
|
71.8 g/L
Standard Deviation 4.54
|
72.2 g/L
Standard Deviation 4.13
|
74.3 g/L
Standard Deviation 4.25
|
70.5 g/L
Standard Deviation 4.84
|
69.2 g/L
Standard Deviation 4.22
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin.
Baseline(Albumin)
|
42.9 g/L
Standard Deviation 6.75
|
44.3 g/L
Standard Deviation 1.84
|
44.4 g/L
Standard Deviation 2.53
|
44.7 g/L
Standard Deviation 2.53
|
43.2 g/L
Standard Deviation 2.67
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase
Baseline (Alkaline Phosphatase)
|
1.587 ukat/L
Standard Deviation 0.4829
|
1.397 ukat/L
Standard Deviation 0.3233
|
1.364 ukat/L
Standard Deviation 0.3219
|
1.397 ukat/L
Standard Deviation 0.3271
|
1.407 ukat/L
Standard Deviation 0.4417
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase
Day 14 Change from Baseline (Alkaline Phosphatase)
|
-0.129 ukat/L
Standard Deviation 0.3411
|
-0.130 ukat/L
Standard Deviation 0.2054
|
-0.172 ukat/L
Standard Deviation 0.1533
|
-0.203 ukat/L
Standard Deviation 0.2576
|
-0.131 ukat/L
Standard Deviation 0.2958
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase
Baseline(Alanine Aminotransferase)
|
0.295 ukat/L
Standard Deviation 0.1302
|
0.331 ukat/L
Standard Deviation 0.1494
|
0.279 ukat/L
Standard Deviation 0.1151
|
0.313 ukat/L
Standard Deviation 0.1281
|
0.413 ukat/L
Standard Deviation 0.1755
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase
Day 14 Change from Baseline (Alanine Aminotransferase)
|
0.108 ukat/L
Standard Deviation 0.4103
|
-0.049 ukat/L
Standard Deviation 0.1053
|
0.049 ukat/L
Standard Deviation 0,2099
|
-0.016 ukat/L
Standard Deviation 0.1391
|
0.052 ukat/L
Standard Deviation 0.3923
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase
Baseline (Aspartate Aminotransferase)
|
0.344 ukat/L
Standard Deviation 0.0760
|
0.355 ukat/L
Standard Deviation 0.0632
|
0.343 ukat/L
Standard Deviation 0.0950
|
0.352 ukat/L
Standard Deviation 0.0737
|
0.401 ukat/L
Standard Deviation 0.1976
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase
Day 14 Change from Baseline (Aspartate Aminotransferase)
|
0.041 ukat/L
Standard Deviation 0.2197
|
-0.035 ukat/L
Standard Deviation 0.0542
|
-0.032 ukat/L
Standard Deviation 0.1030
|
-0.009 ukat/L
Standard Deviation 0.0743
|
-0.032 ukat/L
Standard Deviation 0.2851
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase
Baseline (Gamma Glutamyl Transferase)
|
0.309 ukat/L
Standard Deviation 0.1740
|
0.324 ukat/L
Standard Deviation 0.2085
|
0.397 ukat/L
Standard Deviation 0.2111
|
0.561 ukat/L
Standard Deviation 0.7998
|
0.372 ukat/L
Standard Deviation 0.2272
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase
Baseline (Creatine Kinase)
|
1.957 ukat/L
Standard Deviation 0.8872
|
2.047 ukat/L
Standard Deviation 1.0146
|
1.907 ukat/L
Standard Deviation 1.1933
|
1.895 ukat/L
Standard Deviation 1.2638
|
1.886 ukat/L
Standard Deviation 1.1854
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase
Day 14 Change from Baseline (Gamma Glutamyl Transferase)
|
0.101 ukat/L
Standard Deviation 0.3890
|
-0.035 ukat/L
Standard Deviation 0.0980
|
0.001 ukat/L
Standard Deviation 0.1606
|
-0.190 ukat/L
Standard Deviation 0.4620
|
0.015 ukat/L
Standard Deviation 0.1959
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase
Day 14 Change from Baseline (Creatine Kinase)
|
0.021 ukat/L
Standard Deviation 0.9758
|
-0.260 ukat/L
Standard Deviation 0.4338
|
-0.252 ukat/L
Standard Deviation 0.5078
|
-0.038 ukat/L
Standard Deviation 0.5689
|
-0.269 ukat/L
Standard Deviation 0.5032
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Urate, Bilirubin and Creatinine were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine.
Baseline (Bilirubin)
|
7.61 umol/L
Standard Deviation 3.500
|
8.44 umol/L
Standard Deviation 3.640
|
7.19 umol/L
Standard Deviation 2.932
|
6.96 umol/L
Standard Deviation 2.652
|
7.23 umol/L
Standard Deviation 3.305
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine.
Day 14 Change from Baseline(Creatinine)
|
2.652 umol/L
Standard Deviation 6.4810
|
-1.885 umol/L
Standard Deviation 7.8090
|
-4.168 umol/L
Standard Deviation 7.6761
|
-1.297 umol/L
Standard Deviation 6.6136
|
-3.605 umol/L
Standard Deviation 5.6665
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine.
Baseline (Urate)
|
297.43 umol/L
Standard Deviation 41.896
|
318.23 umol/L
Standard Deviation 20.323
|
261.74 umol/L
Standard Deviation 57.222
|
275.34 umol/L
Standard Deviation 75.528
|
212.17 umol/L
Standard Deviation 52.885
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine.
Day 14 Change from Baseline (Urate)
|
-11.90 umol/L
Standard Deviation 41.380
|
-2.95 umol/L
Standard Deviation 28.511
|
2.57 umol/L
Standard Deviation 19.706
|
-12.76 umol/L
Standard Deviation 28.636
|
-7.93 umol/L
Standard Deviation 44.269
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine.
Day 14 Change from Baseline(Bilirubin)
|
-1.25 umol/L
Standard Deviation 3.225
|
-1.15 umol/L
Standard Deviation 2.654
|
-1.00 umol/L
Standard Deviation 1.886
|
-0.01 umol/L
Standard Deviation 2.599
|
0.40 umol/L
Standard Deviation 3.069
|
|
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine.
Baseline(Creatinine)
|
71.162 umol/L
Standard Deviation 11.3215
|
67.125 umol/L
Standard Deviation 8.0711
|
65.121 umol/L
Standard Deviation 9.8867
|
67.891 umol/L
Standard Deviation 9.1636
|
11.844 umol/L
Standard Deviation 8.9096
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen were collected upon participant's admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Day 14 Change from Baseline (Potassium)
|
0.06 mmol/L
Standard Deviation 0.478
|
0.22 mmol/L
Standard Deviation 0.323
|
0.15 mmol/L
Standard Deviation 0.427
|
-0.06 mmol/L
Standard Deviation 0.408
|
0.31 mmol/L
Standard Deviation 0.614
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Baseline (Chloride)
|
102.8 mmol/L
Standard Deviation 2.94
|
102.4 mmol/L
Standard Deviation 3.79
|
100.7 mmol/L
Standard Deviation 2.32
|
102.7 mmol/L
Standard Deviation 2.84
|
101.4 mmol/L
Standard Deviation 1.56
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Day 14 Change from Baseline ( Chloride)
|
-1.2 mmol/L
Standard Deviation 3.20
|
0.4 mmol/L
Standard Deviation 3.16
|
1.1 mmol/L
Standard Deviation 1.69
|
-1.1 mmol/L
Standard Deviation 3.02
|
0.8 mmol/L
Standard Deviation 2.88
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Baseline (Urea Nitrogen)
|
5.59 mmol/L
Standard Deviation 1.230
|
5.47 mmol/L
Standard Deviation 1.337
|
4.67 mmol/L
Standard Deviation 1.274
|
5.30 mmol/L
Standard Deviation 1.198
|
5.21 mmol/L
Standard Deviation 1.393
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Day 14 Change from Baseline (Urea Nitrogen)
|
0.14 mmol/L
Standard Deviation 2.359
|
-0.14 mmol/L
Standard Deviation 1.070
|
0.20 mmol/L
Standard Deviation 0.826
|
0.00 mmol/L
Standard Deviation 1.442
|
-0.38 mmol/L
Standard Deviation 1.488
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Baseline (Sodium)
|
140.7 mmol/L
Standard Deviation 2.93
|
140.3 mmol/L
Standard Deviation 2.05
|
140.0 mmol/L
Standard Deviation 1.65
|
142.3 mmol/L
Standard Deviation 3.01
|
140.0 mmol/L
Standard Deviation 2.83
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Day 14 Change from Baseline (Sodium)
|
-0.9 mmol/L
Standard Deviation 2.91
|
-0.7 mmol/L
Standard Deviation 2.97
|
-0.5 mmol/L
Standard Deviation 2.28
|
-2.5 mmol/L
Standard Deviation 3.23
|
0.7 mmol/L
Standard Deviation 3.47
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Baseline (Potassium)
|
4.41 mmol/L
Standard Deviation 0.375
|
4.22 mmol/L
Standard Deviation 0.246
|
4.29 mmol/L
Standard Deviation 0.374
|
4.49 mmol/L
Standard Deviation 0.380
|
4.14 mmol/L
Standard Deviation 0.421
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Baseline (Bicarbonate)
|
26.39 mmol/L
Standard Deviation 2.615
|
26.60 mmol/L
Standard Deviation 2.131
|
27.47 mmol/L
Standard Deviation 1.642
|
26.20 mmol/L
Standard Deviation 1.699
|
27.62 mmol/L
Standard Deviation 3.641
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Day 14 Change from Baseline (Bicarbonate)
|
1.11 mmol/L
Standard Deviation 3.660
|
-0.93 mmol/L
Standard Deviation 3.575
|
1.00 mmol/L
Standard Deviation 3.088
|
2.00 mmol/L
Standard Deviation 2.204
|
0.31 mmol/L
Standard Deviation 2.626
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Baseline (Calcium)
|
2.421 mmol/L
Standard Deviation 0.0803
|
2.401 mmol/L
Standard Deviation 0.0730
|
2.515 mmol/L
Standard Deviation 0.0998
|
2.411 mmol/L
Standard Deviation 0.0622
|
2.382 mmol/L
Standard Deviation 0.0928
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Day 14 Change from Baseline (Calcium)
|
-0.032 mmol/L
Standard Deviation 0.1198
|
-0.044 mmol/L
Standard Deviation 0.1355
|
-0.144 mmol/L
Standard Deviation 0.1147
|
-0.049 mmol/L
Standard Deviation 0.0630
|
-0.052 mmol/L
Standard Deviation 0.1103
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Baseline (Phosphate)
|
1.240 mmol/L
Standard Deviation 0.1510
|
1.249 mmol/L
Standard Deviation 0.1277
|
1.268 mmol/L
Standard Deviation 0.1269
|
1.280 mmol/L
Standard Deviation 0.1115
|
1.272 mmol/L
Standard Deviation 0.1544
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Day 14 Change from Baseline (Phosphate)
|
0.026 mmol/L
Standard Deviation 0.1602
|
-0.045 mmol/L
Standard Deviation 0.1457
|
-0.052 mmol/L
Standard Deviation 0.1096
|
0.027 mmol/L
Standard Deviation 0.1389
|
-0.038 mmol/L
Standard Deviation 0.2171
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Baseline (Glucose)
|
5.457 mmol/L
Standard Deviation 0.6417
|
5.521 mmol/L
Standard Deviation 0.4157
|
5.349 mmol/L
Standard Deviation 0.4957
|
5.483 mmol/L
Standard Deviation 0.3943
|
5.456 mmol/L
Standard Deviation 0.4401
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Day 14 Change from Baseline (Glucose)
|
-0.113 mmol/L
Standard Deviation 0.9083
|
-0.278 mmol/L
Standard Deviation 0.4006
|
-0.173 mmol/L
Standard Deviation 0.3412
|
-0.098 mmol/L
Standard Deviation 0.4245
|
0.025 mmol/L
Standard Deviation 0.3063
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Baseline (Magnesium)
|
0.893 mmol/L
Standard Deviation 0.0732
|
0.885 mmol/L
Standard Deviation 0.0588
|
0.881 mmol/L
Standard Deviation 0.0675
|
0.905 mmol/L
Standard Deviation 0.0703
|
0.896 mmol/L
Standard Deviation 0.0836
|
|
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Day 14 Change from Baseline (Magnesium)
|
-0.009 mmol/L
Standard Deviation 0.0460
|
0.001 mmol/L
Standard Deviation 0.0387
|
0.001 mmol/L
Standard Deviation 0.0529
|
0.006 mmol/L
Standard Deviation 0.0484
|
-0.027 mmol/L
Standard Deviation 0.0696
|
PRIMARY outcome
Timeframe: At BaselinePopulation: Participants with available data reported. Baseline is the last available measurement prior to the first dose of study drug.
Blood samples for the assessment of Glomerular Filtration Rate African were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline
|
1.628 mL/sec/1.73m^2
Standard Deviation 0.2347
|
1.759 mL/sec/1.73m^2
Standard Deviation 0.1592
|
1.580 mL/sec/1.73m^2
Standard Deviation 0.1846
|
1.557 mL/sec/1.73m^2
Standard Deviation 0.1553
|
1.666 mL/sec/1.73m^2
Standard Deviation 0.1885
|
PRIMARY outcome
Timeframe: At BaselinePopulation: Participants with available data reported. Baseline is the last available measurement prior to the first dose of study drug.
Blood samples for the assessment of Glomerular Filtration Rate Caucasian were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline
|
1.343 mL/sec/1.73m^2
Standard Deviation 0.1955
|
1.450 mL/sec/1.73m^2
Standard Deviation 0.1265
|
1.300 mL/sec/1.73m^2
Standard Deviation 0.1503
|
1.290 mL/sec/1.73m^2
Standard Deviation 0.1273
|
1.378 mL/sec/1.73m^2
Standard Deviation 0.1482
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Prothrombin International Normalized Ratio were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR)
Baseline
|
0.993 INR
Standard Deviation 0.0428
|
1.013 INR
Standard Deviation 0.0552
|
1.007 INR
Standard Deviation 0.0482
|
0.991 INR
Standard Deviation 0.0465
|
0.993 INR
Standard Deviation 0.0645
|
|
Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR)
Day 14 Change from Baseline
|
-0.007 INR
Standard Deviation 0.0546
|
-0.038 INR
Standard Deviation 0.0471
|
0.016 INR
Standard Deviation 0.0665
|
0.013 INR
Standard Deviation 0.0359
|
0.057 INR
Standard Deviation 0.2311
|
PRIMARY outcome
Timeframe: Baseline and day 14Population: Participants with available data reported.
Blood samples for the assessment of Prothrombin Time and Activated Partial Thromboplastin Time were collected upon participants admission to the unit.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time
Day 14 Change from Baseline (Prothrombin Time)
|
-0.15 sec
Standard Deviation 0.507
|
-0.32 sec
Standard Deviation 0.351
|
0.12 sec
Standard Deviation 0.503
|
0.11 sec
Standard Deviation 0.291
|
0.55 sec
Standard Deviation 2.363
|
|
Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time
Day 14 Change from Baseline (Activated Partial Thromboplastin Time)
|
-0.82 sec
Standard Deviation 1.350
|
-1.80 sec
Standard Deviation 1.489
|
-0.81 sec
Standard Deviation 1.478
|
-0.87 sec
Standard Deviation 1.396
|
0.58 sec
Standard Deviation 3.196
|
|
Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time
Baseline (Prothrombin Time )
|
11.17 sec
Standard Deviation 1.871
|
11.05 sec
Standard Deviation 1.679
|
11.91 sec
Standard Deviation 1.871
|
11.51 sec
Standard Deviation 1.757
|
11.47 sec
Standard Deviation 1.589
|
|
Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time
Baseline(Activated Partial Thromboplastin Time)
|
26.91 sec
Standard Deviation 2.435
|
27.09 sec
Standard Deviation 2.495
|
28.14 sec
Standard Deviation 2.483
|
27.50 sec
Standard Deviation 2.872
|
27.55 sec
Standard Deviation 3.009
|
PRIMARY outcome
Timeframe: Baseline (day -1) and day 14Population: Participants with available data reported.
Heart rate was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made.Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day -1(Predose)
|
65.7 beats/min
Standard Deviation 9.50
|
61.6 beats/min
Standard Deviation 6.43
|
65.3 beats/min
Standard Deviation 8.43
|
64.5 beats/min
Standard Deviation 5.85
|
65.0 beats/min
Standard Deviation 7.16
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day -1 (4 hour)
|
68.0 beats/min
Standard Deviation 10.50
|
62.8 beats/min
Standard Deviation 6.70
|
64.3 beats/min
Standard Deviation 6.20
|
63.9 beats/min
Standard Deviation 5.54
|
67.5 beats/min
Standard Deviation 8.40
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day -1 (8 hour)
|
72.9 beats/min
Standard Deviation 10.38
|
64.4 beats/min
Standard Deviation 5.95
|
70.2 beats/min
Standard Deviation 10.68
|
66.9 beats/min
Standard Deviation 7.17
|
70.2 beats/min
Standard Deviation 8.14
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day -1 (12 hour)
|
77.0 beats/min
Standard Deviation 9.63
|
68.7 beats/min
Standard Deviation 8.96
|
73.6 beats/min
Standard Deviation 7.43
|
70.7 beats/min
Standard Deviation 7.81
|
71.6 beats/min
Standard Deviation 8.69
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day 14 (Pre dose) Change from Baseline
|
-0.4 beats/min
Standard Deviation 6.87
|
-0.3 beats/min
Standard Deviation 4.08
|
0.8 beats/min
Standard Deviation 6.14
|
-2.1 beats/min
Standard Deviation 6.96
|
-3.8 beats/min
Standard Deviation 8.85
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day 14 (0.5 hour) Change from Baseline
|
-2.6 beats/min
Standard Deviation 7.58
|
-5.1 beats/min
Standard Deviation 8.48
|
-0.9 beats/min
Standard Deviation 10.10
|
-4.3 beats/min
Standard Deviation 10.24
|
-9.6 beats/min
Standard Deviation 10.13
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day 14 (1 hour) Change from Baseline
|
-5.0 beats/min
Standard Deviation 8.66
|
-6.7 beats/min
Standard Deviation 9.65
|
-0.6 beats/min
Standard Deviation 9.18
|
-7.9 beats/min
Standard Deviation 8.35
|
-7.7 beats/min
Standard Deviation 6.92
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day 14 (1.5 hour) Change from Baseline
|
-5.5 beats/min
Standard Deviation 8.13
|
-7.4 beats/min
Standard Deviation 7.24
|
-1.5 beats/min
Standard Deviation 7.10
|
-7.9 beats/min
Standard Deviation 8.07
|
-7.6 beats/min
Standard Deviation 8.08
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day 14 (2 hour) Change from Baseline
|
-6.5 beats/min
Standard Deviation 10.98
|
-7.9 beats/min
Standard Deviation 7.98
|
-2.4 beats/min
Standard Deviation 8.54
|
-4.2 beats/min
Standard Deviation 7.90
|
-7.0 beats/min
Standard Deviation 6.94
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day 14 (2.5 hour) Change from Baseline
|
-4.2 beats/min
Standard Deviation 7.16
|
-10.5 beats/min
Standard Deviation 8.60
|
-0.3 beats/min
Standard Deviation 7.05
|
-4.2 beats/min
Standard Deviation 4.95
|
-7.8 beats/min
Standard Deviation 10.48
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day 14 (3 hour) Change from Baseline
|
-4.9 beats/min
Standard Deviation 9.94
|
-4.6 beats/min
Standard Deviation 5.05
|
-0.4 beats/min
Standard Deviation 8.45
|
-7.5 beats/min
Standard Deviation 7.74
|
-5.7 beats/min
Standard Deviation 9.94
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day 14 (4 hour) Change from Baseline
|
-4.3 beats/min
Standard Deviation 8.57
|
-2.9 beats/min
Standard Deviation 4.83
|
0.2 beats/min
Standard Deviation 8.86
|
-2.0 beats/min
Standard Deviation 7.36
|
-5.8 beats/min
Standard Deviation 7.62
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day 14 (8 hour) Change from Baseline
|
-2.2 beats/min
Standard Deviation 6.22
|
0.5 beats/min
Standard Deviation 5.15
|
6.8 beats/min
Standard Deviation 8.99
|
1.0 beats/min
Standard Deviation 6.47
|
-2.3 beats/min
Standard Deviation 9.40
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day 14 (12 hour) Change from Baseline
|
-0.9 beats/min
Standard Deviation 5.70
|
0.7 beats/min
Standard Deviation 5.74
|
2.3 beats/min
Standard Deviation 8.26
|
0.0 beats/min
Standard Deviation 5.49
|
-3.2 beats/min
Standard Deviation 9.57
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day -1 (0.5 hour)
|
68.5 beats/min
Standard Deviation 9.54
|
64.5 beats/min
Standard Deviation 8.76
|
66.7 beats/min
Standard Deviation 10.56
|
66.1 beats/min
Standard Deviation 9.13
|
68.7 beats/min
Standard Deviation 9.94
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day -1 (1 hour)
|
69.8 beats/min
Standard Deviation 9.27
|
66.8 beats/min
Standard Deviation 9.58
|
66.2 beats/min
Standard Deviation 9.31
|
67.6 beats/min
Standard Deviation 5.69
|
67.2 beats/min
Standard Deviation 7.77
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day -1 (1.5 hour)
|
68.9 beats/min
Standard Deviation 9.26
|
67.3 beats/min
Standard Deviation 7.24
|
66.5 beats/min
Standard Deviation 9.09
|
67.3 beats/min
Standard Deviation 5.38
|
67.5 beats/min
Standard Deviation 7.37
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day -1 (2 hour)
|
70.2 beats/min
Standard Deviation 10.95
|
67.3 beats/min
Standard Deviation 7.81
|
65.9 beats/min
Standard Deviation 9.96
|
65.2 beats/min
Standard Deviation 4.38
|
66.3 beats/min
Standard Deviation 8.36
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day -1 (2.5 hour)
|
68.7 beats/min
Standard Deviation 9.02
|
69.4 beats/min
Standard Deviation 8.86
|
64.6 beats/min
Standard Deviation 10.11
|
65.1 beats/min
Standard Deviation 4.19
|
68.2 beats/min
Standard Deviation 10.32
|
|
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Day -1 (3 hour)
|
69.4 beats/min
Standard Deviation 9.06
|
64.3 beats/min
Standard Deviation 4.91
|
65.6 beats/min
Standard Deviation 7.89
|
67.9 beats/min
Standard Deviation 5.79
|
68.8 beats/min
Standard Deviation 7.51
|
PRIMARY outcome
Timeframe: Baseline (day -1) and day 14Population: Participants with available data reported.
PR Interval was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day -1 (Predose)
|
165.3 msec
Standard Deviation 22.20
|
152.6 msec
Standard Deviation 14.30
|
165.3 msec
Standard Deviation 26.10
|
166.6 msec
Standard Deviation 26.74
|
162.6 msec
Standard Deviation 20.52
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day -1 (0.5 hour)
|
163.3 msec
Standard Deviation 24.69
|
155.3 msec
Standard Deviation 20.19
|
167.1 msec
Standard Deviation 26.74
|
162.1 msec
Standard Deviation 22.13
|
162.4 msec
Standard Deviation 20.59
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day -1 (1 hour)
|
166.3 msec
Standard Deviation 23.76
|
155.7 msec
Standard Deviation 20.43
|
166.6 msec
Standard Deviation 25.79
|
166.5 msec
Standard Deviation 24.32
|
162.1 msec
Standard Deviation 19.82
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day -1 (1.5 hour)
|
167.6 msec
Standard Deviation 22.91
|
158.9 msec
Standard Deviation 17.73
|
165.9 msec
Standard Deviation 21.47
|
164.9 msec
Standard Deviation 26.07
|
162.4 msec
Standard Deviation 17.60
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day -1 (2 hour)
|
166.9 msec
Standard Deviation 25.01
|
156.0 msec
Standard Deviation 18.95
|
167.1 msec
Standard Deviation 22.27
|
164.9 msec
Standard Deviation 25.23
|
162.9 msec
Standard Deviation 21.16
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day -1 (2.5 hour)
|
168.7 msec
Standard Deviation 26.32
|
155.3 msec
Standard Deviation 18.32
|
165.8 msec
Standard Deviation 26.24
|
165.2 msec
Standard Deviation 26.51
|
160.4 msec
Standard Deviation 21.99
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day -1 (3 hour)
|
168.0 msec
Standard Deviation 25.66
|
153.7 msec
Standard Deviation 17.61
|
170.1 msec
Standard Deviation 31.39
|
161.8 msec
Standard Deviation 23.66
|
160.1 msec
Standard Deviation 20.10
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day -1 (12 hour)
|
165.7 msec
Standard Deviation 26.90
|
157.7 msec
Standard Deviation 17.41
|
158.5 msec
Standard Deviation 19.56
|
159.0 msec
Standard Deviation 21.78
|
156.5 msec
Standard Deviation 17.71
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day 14 (Pre dose) Change from Baseline
|
5.6 msec
Standard Deviation 12.32
|
1.7 msec
Standard Deviation 6.41
|
-1.8 msec
Standard Deviation 10.85
|
-0.3 msec
Standard Deviation 9.42
|
0.9 msec
Standard Deviation 12.78
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day 14 (0.5 hour) Change from Baseline
|
8.5 msec
Standard Deviation 20.00
|
0.4 msec
Standard Deviation 6.90
|
0.9 msec
Standard Deviation 14.64
|
4.6 msec
Standard Deviation 12.49
|
-0.8 msec
Standard Deviation 13.90
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day 14 (2.5 hour) Change from Baseline
|
2.2 msec
Standard Deviation 9.34
|
2.6 msec
Standard Deviation 13.33
|
0.0 msec
Standard Deviation 11.96
|
1.8 msec
Standard Deviation 12.11
|
8.3 msec
Standard Deviation 15.96
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day 14 (3 hour) Change from Baseline
|
3.8 msec
Standard Deviation 11.09
|
5.3 msec
Standard Deviation 11.40
|
-3.1 msec
Standard Deviation 10.83
|
4.5 msec
Standard Deviation 15.01
|
4.9 msec
Standard Deviation 14.78
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day 14 (4 hour) Change from Baseline
|
5.7 msec
Standard Deviation 15.13
|
1.4 msec
Standard Deviation 6.48
|
5.2 msec
Standard Deviation 20.77
|
1.8 msec
Standard Deviation 14.49
|
2.2 msec
Standard Deviation 9.05
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day 14 (8 hour) Change from Baseline
|
1.4 msec
Standard Deviation 8.66
|
2.9 msec
Standard Deviation 5.95
|
0.1 msec
Standard Deviation 15.03
|
-3.9 msec
Standard Deviation 12.21
|
5.2 msec
Standard Deviation 6.54
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day -1 (4 hour)
|
165.6 msec
Standard Deviation 24.06
|
155.4 msec
Standard Deviation 17.27
|
165.1 msec
Standard Deviation 20.73
|
163.6 msec
Standard Deviation 26.48
|
161.6 msec
Standard Deviation 16.78
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day -1 (8 hour)
|
162.1 msec
Standard Deviation 23.67
|
152.5 msec
Standard Deviation 17.45
|
161.7 msec
Standard Deviation 22.93
|
163.5 msec
Standard Deviation 25.00
|
156.4 msec
Standard Deviation 16.60
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day 14 (1 hour) Change from Baseline
|
5.6 msec
Standard Deviation 15.88
|
2.8 msec
Standard Deviation 9.03
|
-1.0 msec
Standard Deviation 14.15
|
2.7 msec
Standard Deviation 19.24
|
1.7 msec
Standard Deviation 13.74
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day 14 (1.5 hour) Change from Baseline
|
-1.0 msec
Standard Deviation 12.86
|
-2.8 msec
Standard Deviation 9.59
|
3.9 msec
Standard Deviation 17.63
|
-0.5 msec
Standard Deviation 11.47
|
1.8 msec
Standard Deviation 17.08
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day 14 (2 hour) Change from Baseline
|
4.1 msec
Standard Deviation 12.56
|
0.6 msec
Standard Deviation 8.85
|
-0.9 msec
Standard Deviation 17.72
|
0.9 msec
Standard Deviation 11.82
|
4.2 msec
Standard Deviation 14.32
|
|
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Day 14 (12 hour) Change from Baseline
|
-0.4 msec
Standard Deviation 8.83
|
-3.6 msec
Standard Deviation 9.17
|
-0.1 msec
Standard Deviation 11.07
|
2.0 msec
Standard Deviation 9.33
|
0.9 msec
Standard Deviation 10.80
|
PRIMARY outcome
Timeframe: Baseline (day -1) and day 14Population: Participants with available data reported.
QRS Duration was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day -1 (0.5 hour
|
88.7 msec
Standard Deviation 10.44
|
94.5 msec
Standard Deviation 7.94
|
87.4 msec
Standard Deviation 8.44
|
88.5 msec
Standard Deviation 10.86
|
88.9 msec
Standard Deviation 10.73
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day -1 (1 hour)
|
88.7 msec
Standard Deviation 10.22
|
93.3 msec
Standard Deviation 7.17
|
85.2 msec
Standard Deviation 7.94
|
90.3 msec
Standard Deviation 9.91
|
91.2 msec
Standard Deviation 13.04
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day -1 (1.5 hour)
|
89.4 msec
Standard Deviation 11.77
|
91.7 msec
Standard Deviation 8.52
|
85.0 msec
Standard Deviation 7.98
|
89.5 msec
Standard Deviation 10.20
|
92.2 msec
Standard Deviation 11.59
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day -1 (2 hour)
|
86.4 msec
Standard Deviation 11.08
|
90.5 msec
Standard Deviation 7.98
|
84.0 msec
Standard Deviation 5.83
|
89.5 msec
Standard Deviation 11.15
|
89.0 msec
Standard Deviation 10.04
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day -1 (3 hour)
|
86.4 msec
Standard Deviation 10.10
|
92.7 msec
Standard Deviation 6.94
|
85.7 msec
Standard Deviation 9.32
|
88.6 msec
Standard Deviation 10.10
|
87.9 msec
Standard Deviation 11.06
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day -1 (4 hour)
|
86.2 msec
Standard Deviation 11.68
|
92.3 msec
Standard Deviation 8.26
|
85.1 msec
Standard Deviation 9.68
|
87.7 msec
Standard Deviation 11.04
|
88.7 msec
Standard Deviation 11.53
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day 14 (1 hour) Change from Baseline
|
0.7 msec
Standard Deviation 6.66
|
0.0 msec
Standard Deviation 3.57
|
-1.6 msec
Standard Deviation 7.46
|
-0.1 msec
Standard Deviation 8.88
|
-2.5 msec
Standard Deviation 10.73
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day 14 (1.5 hour) Change from Baseline
|
-0.8 msec
Standard Deviation 6.00
|
1.5 msec
Standard Deviation 6.83
|
-2.0 msec
Standard Deviation 6.26
|
3.4 msec
Standard Deviation 6.74
|
-1.8 msec
Standard Deviation 8.62
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day 14 (2 hour) Change from Baseline
|
1.7 msec
Standard Deviation 8.08
|
3.2 msec
Standard Deviation 5.87
|
-0.8 msec
Standard Deviation 5.25
|
1.9 msec
Standard Deviation 8.34
|
1.0 msec
Standard Deviation 8.08
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day 14 (2.5 hour) Change from Baseline
|
1.7 msec
Standard Deviation 7.13
|
0.9 msec
Standard Deviation 4.96
|
0.4 msec
Standard Deviation 7.02
|
1.2 msec
Standard Deviation 5.61
|
3.4 msec
Standard Deviation 7.39
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day 14 (3 hour) Change from Baseline
|
2.2 msec
Standard Deviation 5.41
|
0.5 msec
Standard Deviation 4.87
|
-1.5 msec
Standard Deviation 6.56
|
-1.5 msec
Standard Deviation 7.06
|
2.6 msec
Standard Deviation 8.90
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day 14 (8 hour) Change from Baseline
|
-0.3 msec
Standard Deviation 3.82
|
1.5 msec
Standard Deviation 4.63
|
0.4 msec
Standard Deviation 3.41
|
0.9 msec
Standard Deviation 6.26
|
2.5 msec
Standard Deviation 6.05
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day 14 (12 hour) Change from Baseline
|
-1.7 msec
Standard Deviation 6.91
|
0.3 msec
Standard Deviation 2.85
|
-3.3 msec
Standard Deviation 9.28
|
-0.5 msec
Standard Deviation 5.49
|
-0.8 msec
Standard Deviation 7.69
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day -1(Predose)
|
88.8 msec
Standard Deviation 10.82
|
93.6 msec
Standard Deviation 8.11
|
84.7 msec
Standard Deviation 6.39
|
89.2 msec
Standard Deviation 10.99
|
89.5 msec
Standard Deviation 11.76
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day -1 (2.5 hour)
|
87.6 msec
Standard Deviation 12.27
|
91.5 msec
Standard Deviation 8.94
|
84.4 msec
Standard Deviation 8.22
|
89.0 msec
Standard Deviation 10.27
|
87.8 msec
Standard Deviation 10.80
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day -1 (8 hour)
|
85.4 msec
Standard Deviation 11.26
|
90.9 msec
Standard Deviation 9.16
|
81.1 msec
Standard Deviation 4.41
|
85.4 msec
Standard Deviation 11.79
|
85.3 msec
Standard Deviation 11.46
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day -1 (12 hour)
|
86.6 msec
Standard Deviation 10.53
|
92.0 msec
Standard Deviation 7.93
|
85.5 msec
Standard Deviation 9.13
|
86.3 msec
Standard Deviation 10.55
|
88.1 msec
Standard Deviation 13.08
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day 14 (Pre dose) Change from Baseline
|
-0.7 msec
Standard Deviation 3.63
|
0.3 msec
Standard Deviation 3.89
|
-0.8 msec
Standard Deviation 4.56
|
-0.1 msec
Standard Deviation 6.71
|
3.1 msec
Standard Deviation 7.80
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day 14 (0.5 hour) Change from Baseline
|
1.0 msec
Standard Deviation 7.64
|
-1.2 msec
Standard Deviation 5.87
|
-3.1 msec
Standard Deviation 5.37
|
0.4 msec
Standard Deviation 6.53
|
2.8 msec
Standard Deviation 5.06
|
|
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Day 14 (4 hour) Change from Baseline
|
1.9 msec
Standard Deviation 6.27
|
0.5 msec
Standard Deviation 4.61
|
-2.5 msec
Standard Deviation 6.44
|
14.8 msec
Standard Deviation 49.01
|
1.7 msec
Standard Deviation 7.80
|
PRIMARY outcome
Timeframe: Baseline (day -1) and day 14Population: Participants with available data reported.
QT Interval was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day -1 (Predose)
|
421.8 msec
Standard Deviation 31.07
|
426.4 msec
Standard Deviation 23.73
|
412.6 msec
Standard Deviation 29.12
|
421.8 msec
Standard Deviation 22.12
|
411.3 msec
Standard Deviation 16.01
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day -1 (0.5 hour
|
412.4 msec
Standard Deviation 27.58
|
422.0 msec
Standard Deviation 24.00
|
410.1 msec
Standard Deviation 29.29
|
417.7 msec
Standard Deviation 22.13
|
405.6 msec
Standard Deviation 22.19
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day -1 (1 hour)
|
412.6 msec
Standard Deviation 22.81
|
414.6 msec
Standard Deviation 21.41
|
415.6 msec
Standard Deviation 29.17
|
414.8 msec
Standard Deviation 21.32
|
406.5 msec
Standard Deviation 21.20
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day -1 (2 hour)
|
407.4 msec
Standard Deviation 25.64
|
405.8 msec
Standard Deviation 19.18
|
410.7 msec
Standard Deviation 33.40
|
413.4 msec
Standard Deviation 20.20
|
412.7 msec
Standard Deviation 22.32
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day -1 (2.5 hour)
|
411.3 msec
Standard Deviation 27.10
|
403.4 msec
Standard Deviation 27.70
|
410.9 msec
Standard Deviation 32.10
|
418.9 msec
Standard Deviation 32.10
|
412.4 msec
Standard Deviation 26.30
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day -1 (3 hour)
|
407.8 msec
Standard Deviation 25.47
|
411.9 msec
Standard Deviation 22.80
|
409.9 msec
Standard Deviation 24.92
|
410.7 msec
Standard Deviation 23.04
|
401.2 msec
Standard Deviation 23.18
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day -1 (4 hour)
|
408.3 msec
Standard Deviation 32.47
|
414.9 msec
Standard Deviation 20.19
|
411.2 msec
Standard Deviation 21.83
|
418.1 msec
Standard Deviation 19.01
|
407.8 msec
Standard Deviation 16.98
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day -1 (8 hour)
|
398.9 msec
Standard Deviation 29.10
|
410.3 msec
Standard Deviation 19.54
|
396.3 msec
Standard Deviation 26.84
|
405.7 msec
Standard Deviation 22.57
|
398.5 msec
Standard Deviation 27.65
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day 14 (0.5 hour) Change from Baseline
|
2.3 msec
Standard Deviation 17.73
|
8.7 msec
Standard Deviation 13.13
|
-2.4 msec
Standard Deviation 23.90
|
10.2 msec
Standard Deviation 25.32
|
20.8 msec
Standard Deviation 24.94
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day 14 (1 hour) Change from Baseline
|
6.9 msec
Standard Deviation 18.73
|
17.8 msec
Standard Deviation 15.93
|
-7.9 msec
Standard Deviation 28.71
|
16.3 msec
Standard Deviation 20.43
|
17.8 msec
Standard Deviation 22.08
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day 14 (2 hour) Change from Baseline
|
14.2 msec
Standard Deviation 25.19
|
25.5 msec
Standard Deviation 18.13
|
3.6 msec
Standard Deviation 25.04
|
16.3 msec
Standard Deviation 20.76
|
16.2 msec
Standard Deviation 16.67
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day 14 (8 hour) Change from Baseline
|
2.4 msec
Standard Deviation 14.71
|
-1.9 msec
Standard Deviation 12.65
|
-14.2 msec
Standard Deviation 18.23
|
-3.7 msec
Standard Deviation 20.76
|
6.6 msec
Standard Deviation 27.45
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day 14 (12 hour) Change from Baseline
|
3.0 msec
Standard Deviation 17.62
|
-0.8 msec
Standard Deviation 13.58
|
-12.9 msec
Standard Deviation 18.71
|
-1.8 msec
Standard Deviation 16.37
|
7.8 msec
Standard Deviation 24.27
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day -1 (1.5 hour)
|
413.7 msec
Standard Deviation 23.60
|
408.4 msec
Standard Deviation 19.91
|
408.0 msec
Standard Deviation 23.71
|
414.9 msec
Standard Deviation 21.19
|
412.3 msec
Standard Deviation 22.31
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day -1 (12 hour)
|
389.2 msec
Standard Deviation 28.40
|
407.1 msec
Standard Deviation 22.55
|
395.5 msec
Standard Deviation 22.33
|
402.2 msec
Standard Deviation 26.39
|
394.4 msec
Standard Deviation 28.85
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day 14 (Pre dose) Change from Baseline
|
-6.8 msec
Standard Deviation 17.03
|
0.2 msec
Standard Deviation 15.11
|
-9.6 msec
Standard Deviation 20.16
|
-2.1 msec
Standard Deviation 24.54
|
5.5 msec
Standard Deviation 21.03
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day 14 (1.5 hour) Change from Baseline
|
11.7 msec
Standard Deviation 22.95
|
24.5 msec
Standard Deviation 14.95
|
-0.5 msec
Standard Deviation 19.09
|
15.7 msec
Standard Deviation 21.82
|
17.5 msec
Standard Deviation 21.80
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day 14 (2.5 hour) Change from Baseline
|
9.5 msec
Standard Deviation 25.18
|
28.3 msec
Standard Deviation 22.66
|
1.4 msec
Standard Deviation 24.51
|
12.9 msec
Standard Deviation 21.11
|
14.0 msec
Standard Deviation 23.04
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day 14 (3 hour) Change from Baseline
|
14.2 msec
Standard Deviation 28.90
|
17.4 msec
Standard Deviation 15.42
|
1.9 msec
Standard Deviation 18.66
|
18.3 msec
Standard Deviation 23.65
|
17.8 msec
Standard Deviation 28.64
|
|
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Day 14 (4 hour) Change from Baseline
|
12.6 msec
Standard Deviation 22.90
|
13.5 msec
Standard Deviation 15.04
|
-2.8 msec
Standard Deviation 23.91
|
5.5 msec
Standard Deviation 23.97
|
18.3 msec
Standard Deviation 22.05
|
PRIMARY outcome
Timeframe: Baseline (day -1) and day 14Population: Participants with available data reported.
Fridericia-corrected QTcF interval was evaluated as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day -1(Predose)
|
432.7 msec
Standard Deviation 18.75
|
429.0 msec
Standard Deviation 16.87
|
422.3 msec
Standard Deviation 14.41
|
431.1 msec
Standard Deviation 17.28
|
421.8 msec
Standard Deviation 20.02
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day -1 (1 hour)
|
432.2 msec
Standard Deviation 14.68
|
428.3 msec
Standard Deviation 14.85
|
427.3 msec
Standard Deviation 16.15
|
430.9 msec
Standard Deviation 16.46
|
420.8 msec
Standard Deviation 13.55
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day -1 (1.5 hour)
|
431.7 msec
Standard Deviation 18.47
|
423.4 msec
Standard Deviation 17.60
|
420.6 msec
Standard Deviation 14.81
|
430.5 msec
Standard Deviation 15.73
|
427.6 msec
Standard Deviation 15.24
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day -1 (2 hour)
|
427.2 msec
Standard Deviation 17.33
|
420.5 msec
Standard Deviation 13.47
|
420.9 msec
Standard Deviation 15.57
|
424.5 msec
Standard Deviation 16.55
|
425.2 msec
Standard Deviation 15.08
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day -1 (2.5 hour)
|
428.7 msec
Standard Deviation 19.29
|
422.1 msec
Standard Deviation 21.46
|
418.3 msec
Standard Deviation 17.41
|
429.9 msec
Standard Deviation 18.39
|
428.3 msec
Standard Deviation 17.29
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day -1 (3 hour)
|
426.7 msec
Standard Deviation 16.64
|
420.3 msec
Standard Deviation 18.14
|
419.9 msec
Standard Deviation 15.56
|
427.0 msec
Standard Deviation 15.46
|
419.0 msec
Standard Deviation 17.83
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day -1 (4 hour)
|
423.4 msec
Standard Deviation 19.52
|
420.3 msec
Standard Deviation 18.14
|
419.9 msec
Standard Deviation 14.74
|
426.2 msec
Standard Deviation 13.33
|
423.2 msec
Standard Deviation 19.46
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day -1 (8 hour)
|
423.8 msec
Standard Deviation 16.12
|
419.3 msec
Standard Deviation 15.99
|
415.5 msec
Standard Deviation 17.53
|
419.7 msec
Standard Deviation 16.65
|
418.8 msec
Standard Deviation 25.31
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day -1 (12 hour)
|
421.2 msec
Standard Deviation 16.25
|
424.2 msec
Standard Deviation 13.91
|
422.1 msec
Standard Deviation 11.25
|
423.7 msec
Standard Deviation 20.16
|
416.8 msec
Standard Deviation 20.10
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day 14 (Pre dose) Change from Baseline
|
-6.6 msec
Standard Deviation 11.74
|
0.3 msec
Standard Deviation 12.75
|
-7.9 msec
Standard Deviation 13.31
|
-6.6 msec
Standard Deviation 22.83
|
-3.8 msec
Standard Deviation 13.46
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day 14 (0.5 hour) Change from Baseline
|
-3.0 msec
Standard Deviation 14.97
|
-2.9 msec
Standard Deviation 9.31
|
-4.4 msec
Standard Deviation 10.52
|
1.1 msec
Standard Deviation 14.51
|
0.4 msec
Standard Deviation 12.92
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day 14 (1 hour) Change from Baseline
|
-2.6 msec
Standard Deviation 11.94
|
2.7 msec
Standard Deviation 11.08
|
-8.4 msec
Standard Deviation 12.88
|
-1.2 msec
Standard Deviation 18.18
|
1.6 msec
Standard Deviation 15.34
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day 14 (1.5 hour) Change from Baseline
|
0.1 msec
Standard Deviation 13.97
|
8.3 msec
Standard Deviation 15.45
|
-3.8 msec
Standard Deviation 9.02
|
-2.1 msec
Standard Deviation 15.16
|
0.6 msec
Standard Deviation 15.77
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day 14 (2 hour) Change from Baseline
|
1.3 msec
Standard Deviation 17.40
|
8.7 msec
Standard Deviation 11.48
|
-0.4 msec
Standard Deviation 15.25
|
6.7 msec
Standard Deviation 10.09
|
0.8 msec
Standard Deviation 12.58
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day 14 (2.5 hour) Change from Baseline
|
1.1 msec
Standard Deviation 20.94
|
5.9 msec
Standard Deviation 18.24
|
2.3 msec
Standard Deviation 13.84
|
3.8 msec
Standard Deviation 16.62
|
-2.3 msec
Standard Deviation 12.11
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day 14 (3 hour) Change from Baseline
|
3.6 msec
Standard Deviation 13.91
|
7.0 msec
Standard Deviation 17.29
|
0.3 msec
Standard Deviation 7.71
|
2.2 msec
Standard Deviation 12.14
|
5.5 msec
Standard Deviation 15.08
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day 14 (4 hour) Change from Baseline
|
4.6 msec
Standard Deviation 11.77
|
7.1 msec
Standard Deviation 14.96
|
-3.8 msec
Standard Deviation 11.34
|
0.1 msec
Standard Deviation 15.55
|
6.2 msec
Standard Deviation 22.76
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day 14 (8 hour) Change from Baseline
|
-2.0 msec
Standard Deviation 9.55
|
-1.1 msec
Standard Deviation 10.67
|
-1.3 msec
Standard Deviation 13.74
|
-1.8 msec
Standard Deviation 14.03
|
2.0 msec
Standard Deviation 22.20
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day 14 (12 hour) Change from Baseline
|
1.2 msec
Standard Deviation 14.43
|
1.3 msec
Standard Deviation 10.33
|
-9.4 msec
Standard Deviation 13.78
|
-1.3 msec
Standard Deviation 17.43
|
2.8 msec
Standard Deviation 17.21
|
|
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Day -1 (0.5 hour)
|
429.2 msec
Standard Deviation 16.14
|
430.9 msec
Standard Deviation 18.81
|
422.3 msec
Standard Deviation 14.40
|
430.1 msec
Standard Deviation 16.21
|
422.6 msec
Standard Deviation 15.35
|
PRIMARY outcome
Timeframe: Baseline (day -1) and day 14Population: Participants with available data reported.
Bazett-corrected QTcB interval was evaluated as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day -1 (Predose)
|
438.6 msec
Standard Deviation 18.07
|
430.7 msec
Standard Deviation 18.10
|
427.6 msec
Standard Deviation 13.14
|
436.1 msec
Standard Deviation 17.61
|
417.3 msec
Standard Deviation 25.91
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day -1 (1.5 hour)
|
441.3 msec
Standard Deviation 22.48
|
431.3 msec
Standard Deviation 20.62
|
427.4 msec
Standard Deviation 18.56
|
438.5 msec
Standard Deviation 15.28
|
436.0 msec
Standard Deviation 16.65
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day -1 (2 hour)
|
437.8 msec
Standard Deviation 21.87
|
428.3 msec
Standard Deviation 16.51
|
426.6 msec
Standard Deviation 17.12
|
430.3 msec
Standard Deviation 16.49
|
432.1 msec
Standard Deviation 18.48
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day -1 (4 hour)
|
431.6 msec
Standard Deviation 18.31
|
423.4 msec
Standard Deviation 21.21
|
424.6 msec
Standard Deviation 15.43
|
430.3 msec
Standard Deviation 14.06
|
431.2 msec
Standard Deviation 26.00
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day -1 (12 hour)
|
438.3 msec
Standard Deviation 13.91
|
433.4 msec
Standard Deviation 16.01
|
436.4 msec
Standard Deviation 9.44
|
434.9 msec
Standard Deviation 20.98
|
428.8 msec
Standard Deviation 17.99
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day 14 (Pre dose) Change from Baseline
|
-6.7 msec
Standard Deviation 14.73
|
-0.3 msec
Standard Deviation 13.93
|
-6.9 msec
Standard Deviation 14.02
|
-8.9 msec
Standard Deviation 25.90
|
-8.5 msec
Standard Deviation 17.83
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day 14 (0.5 hour) Change from Baseline
|
-5.9 msec
Standard Deviation 19.59
|
-8.9 msec
Standard Deviation 17.34
|
-5.5 msec
Standard Deviation 13.67
|
-3.4 msec
Standard Deviation 19.47
|
-10.3 msec
Standard Deviation 17.32
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day 14 (2 hour) Change from Baseline
|
-5.7 msec
Standard Deviation 24.18
|
-0.1 msec
Standard Deviation 15.10
|
-2.9 msec
Standard Deviation 19.35
|
1.9 msec
Standard Deviation 13.13
|
-7.5 msec
Standard Deviation 16.37
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day 14 (2.5 hour) Change from Baseline
|
-3.4 msec
Standard Deviation 23.12
|
-5.7 msec
Standard Deviation 22.17
|
2.2 msec
Standard Deviation 15.76
|
-1.4 msec
Standard Deviation 17.37
|
-10.8 msec
Standard Deviation 16.97
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day 14 (3 hour) Change from Baseline
|
-1.6 msec
Standard Deviation 13.90
|
1.9 msec
Standard Deviation 20.81
|
-0.4 msec
Standard Deviation 11.01
|
-6.3 msec
Standard Deviation 12.49
|
-0.7 msec
Standard Deviation 14.57
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day 14 (4 hour) Change from Baseline
|
0.4 msec
Standard Deviation 13.21
|
3.3 msec
Standard Deviation 17.73
|
-4.2 msec
Standard Deviation 12.68
|
-2.2 msec
Standard Deviation 16.13
|
-0.1 msec
Standard Deviation 27.06
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day 14 (8 hour) Change from Baseline
|
-4.4 msec
Standard Deviation 12.46
|
-0.8 msec
Standard Deviation 13.48
|
5.5 msec
Standard Deviation 19.09
|
-0.9 msec
Standard Deviation 14.17
|
-0.2 msec
Standard Deviation 24.65
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day 14 (12 hour) Change from Baseline
|
0.3 msec
Standard Deviation 15.11
|
2.1 msec
Standard Deviation 13.19
|
-7.5 msec
Standard Deviation 16.64
|
-1.2 msec
Standard Deviation 20.57
|
-0.2 msec
Standard Deviation 18.66
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day -1 (0.5 hour)
|
438.1 msec
Standard Deviation 16.29
|
435.6 msec
Standard Deviation 21.78
|
429.1 msec
Standard Deviation 19.47
|
436.5 msec
Standard Deviation 20.61
|
431.8 msec
Standard Deviation 20.32
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day -1 (1 hour)
|
442.8 msec
Standard Deviation 17.55
|
435.3 msec
Standard Deviation 18.84
|
433.7 msec
Standard Deviation 18.90
|
439.4 msec
Standard Deviation 16.23
|
428.8 msec
Standard Deviation 15.65
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day -1 (2.5 hour)
|
438.1 msec
Standard Deviation 21.09
|
432.1 msec
Standard Deviation 22.47
|
422.7 msec
Standard Deviation 19.67
|
435.9 msec
Standard Deviation 18.04
|
436.9 msec
Standard Deviation 21.27
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day -1 (3 hour)
|
436.6 msec
Standard Deviation 18.42
|
425.7 msec
Standard Deviation 22.43
|
426.7 msec
Standard Deviation 16.74
|
435.5 msec
Standard Deviation 13.93
|
428.4 msec
Standard Deviation 19.40
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day -1 (8 hour)
|
437.0 msec
Standard Deviation 14.34
|
424.2 msec
Standard Deviation 17.81
|
425.9 msec
Standard Deviation 21.39
|
427.1 msec
Standard Deviation 18.11
|
429.5 msec
Standard Deviation 27.28
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day 14 (1 hour) Change from Baseline
|
-8.0 msec
Standard Deviation 16.86
|
-4.6 msec
Standard Deviation 19.55
|
-8.9 msec
Standard Deviation 13.33
|
-10.3 msec
Standard Deviation 23.07
|
-7.5 msec
Standard Deviation 16.25
|
|
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Day 14 (1.5 hour) Change from Baseline
|
-6.1 msec
Standard Deviation 16.42
|
0.0 msec
Standard Deviation 21.00
|
-5.5 msec
Standard Deviation 10.36
|
-11.1 msec
Standard Deviation 18.95
|
-8.5 msec
Standard Deviation 19.32
|
PRIMARY outcome
Timeframe: On or after first drug administration up to end of study (Day 21).An AE was defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product. Serious Adverse Event (SAE) is an adverse event that at any dose: Results in death, Is life-threatening (i.e. the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe), Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is considered to be an important medical event.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Nature and Severity of Adverse Events (AEs) up to Day 21
Any TEAE
|
13 Participants
|
7 Participants
|
11 Participants
|
10 Participants
|
11 Participants
|
|
Nature and Severity of Adverse Events (AEs) up to Day 21
Any Mild TEAE
|
12 Participants
|
7 Participants
|
10 Participants
|
10 Participants
|
11 Participants
|
|
Nature and Severity of Adverse Events (AEs) up to Day 21
Any Moderate TEAE
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Nature and Severity of Adverse Events (AEs) up to Day 21
Any Severe TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Severity of Adverse Events (AEs) up to Day 21
Any serious TEAE
|
9 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
11 Participants
|
|
Nature and Severity of Adverse Events (AEs) up to Day 21
Any Causally Related TEAE
|
9 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
11 Participants
|
|
Nature and Severity of Adverse Events (AEs) up to Day 21
Any Life Threatening Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Severity of Adverse Events (AEs) up to Day 21
Any TEAE of Dehydration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Severity of Adverse Events (AEs) up to Day 21
Any Causally Related Serious TEAE
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Severity of Adverse Events (AEs) up to Day 21
Any Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: On or after first drug administration up to end of study (Day 21)An AE was defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product. Serious Adverse Event (SAE) is an adverse event that at any dose: Results in death, Is life-threatening (i.e. the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe), Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is considered to be an important medical event.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Withdrawals Due to AEs up to Day 21
Any TEAE Leading to Discontinuation of Study Drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Withdrawals Due to AEs up to Day 21
Any TEAE Leading to Study Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (day -1) and days 7, 14Population: Participants with available data reported.
Sternal skin conductance monitors (the Bahr MonitorTM) and the associated algorithm software were supplied by Simplex Scientific LLC (Middleton, USA). Participants were instructed to push a button on the skin conductance monitor when they sensed a hot flush when fitted with the monitor and then provide details of the hot flush in the continuous hot flush diary. Sternal skin conductance monitors were fitted on Day -1 (24 hours±1 hour prior to the planned study drug administration on Day 1) and remained in place until after the Day 7 24-hour assessments were completed (on Day 8). Refitted around 30 minutes prior to study drug administration on Day 14 and remained in place until after the 24-hour assessments were completed on Day 15.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance
Baseline ( Day -1)
|
5.486 Hot flushes
Standard Deviation 7.148
|
8.680 Hot flushes
Standard Deviation 4.720
|
7.787 Hot flushes
Standard Deviation 6.153
|
3.200 Hot flushes
Standard Deviation 4.945
|
5.583 Hot flushes
Standard Deviation 7.242
|
|
Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance
Change from Day -1 to Day 7
|
-0.857 Hot flushes
Standard Deviation 6.794
|
-3.986 Hot flushes
Standard Deviation 6.487
|
-3.679 Hot flushes
Standard Deviation 4.670
|
-2.197 Hot flushes
Standard Deviation 4.6090
|
0.000 Hot flushes
Standard Deviation 6.2450
|
|
Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance
Change from Day -1 to day 14
|
-0.139 Hot flushes
Standard Deviation 8.0619
|
-2.642 Hot flushes
Standard Deviation 6.0682
|
-2.913 Hot flushes
Standard Deviation 6.4202
|
0.600 Hot flushes
Standard Deviation 4.9261
|
-2.908 Hot flushes
Standard Deviation 7.1204
|
SECONDARY outcome
Timeframe: Baseline (week -1) and Week 1 ,Week 2Hot flush frequency and hot flush severity were obtained using the Hot Flush paper Diary. Subjects documented the number of individual hot flushes experienced and rated the severity of each on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3). The diaries were completed based on recall twice daily, in the morning and evening.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study
Baseline (Week -1)
|
10.44 Hot flushes
Standard Deviation 3.866
|
12.70 Hot flushes
Standard Deviation 3.385
|
12.04 Hot flushes
Standard Deviation 3.606
|
10.22 Hot flushes
Standard Deviation 2.976
|
9.90 Hot flushes
Standard Deviation 2.107
|
|
Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study
Change from Week -1 to Week 1
|
-2.53 Hot flushes
Standard Deviation 3.645
|
-1.91 Hot flushes
Standard Deviation 4.610
|
-5.35 Hot flushes
Standard Deviation 5.153
|
-6.36 Hot flushes
Standard Deviation 3.818
|
-4.49 Hot flushes
Standard Deviation 2.801
|
|
Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study
Change from Week -1 to Week 2
|
-3.87 Hot flushes
Standard Deviation 4.179
|
-3.07 Hot flushes
Standard Deviation 5.647
|
-7.09 Hot flushes
Standard Deviation 4.915
|
-8.62 Hot flushes
Standard Deviation 3.749
|
-6.54 Hot flushes
Standard Deviation 3.453
|
SECONDARY outcome
Timeframe: Baseline (week -1) and weeks 1, Week 2Participants documented the number of individual hot flushes experienced and rated the severity of each on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3). The diaries were completed based on recall twice daily, in the morning and evening.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary
Change from Week -1 to Week 2
|
-0.34 Scores on a scale
Standard Deviation 0.383
|
-0.23 Scores on a scale
Standard Deviation 0.242
|
-0.36 Scores on a scale
Standard Deviation 0.359
|
-0.88 Scores on a scale
Standard Deviation 0.656
|
-0.42 Scores on a scale
Standard Deviation 0.757
|
|
Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary
Week -1
|
2.32 Scores on a scale
Standard Deviation 0.304
|
2.31 Scores on a scale
Standard Deviation 0.319
|
2.20 Scores on a scale
Standard Deviation 0.267
|
2.16 Scores on a scale
Standard Deviation 0.379
|
2.19 Scores on a scale
Standard Deviation 0.304
|
|
Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary
Change from Week -1 to Week 1
|
-0.30 Scores on a scale
Standard Deviation 0.358
|
-0.21 Scores on a scale
Standard Deviation 0.276
|
-0.23 Scores on a scale
Standard Deviation 0.318
|
-0.51 Scores on a scale
Standard Deviation 0.542
|
-0.34 Scores on a scale
Standard Deviation 0.533
|
SECONDARY outcome
Timeframe: Baseline (week -1) and week 1 , 2The hot flushes severity score was a composite of the frequency and severity of hot flushes, and was calculated as follows: number of mild hot flushes recorded on Day Y + number of moderate hot flushes recorded on Day Y × 2 + number of severe hot flushes recorded on Day Y × 3. Higher scores mean more severe hot flushes.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary.
Week -1
|
28.06 Scores on a scale
Standard Deviation 11.631
|
33.74 Scores on a scale
Standard Deviation 8.875
|
32.52 Scores on a scale
Standard Deviation 11.203
|
27.87 Scores on a scale
Standard Deviation 7.720
|
26.75 Scores on a scale
Standard Deviation 5.416
|
|
Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary.
Change from Week -1 to Week 1
|
-6.99 Scores on a scale
Standard Deviation 9.673
|
-5.56 Scores on a scale
Standard Deviation 10.907
|
-14.48 Scores on a scale
Standard Deviation 14.275
|
-17.03 Scores on a scale
Standard Deviation 9.996
|
-12.23 Scores on a scale
Standard Deviation 7.284
|
|
Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary.
Change from Week -1 to Week 2
|
-10.67 Scores on a scale
Standard Deviation 10.542
|
-8.02 Scores on a scale
Standard Deviation 13.031
|
-19.19 Scores on a scale
Standard Deviation 14.211
|
-22.82 Scores on a scale
Standard Deviation 9.505
|
-17.55 Scores on a scale
Standard Deviation 8.953
|
SECONDARY outcome
Timeframe: Baseline(day -1) and Day 7, 14Population: Participants with available data reported.
Subjects recorded each hot flush and its severity on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3) in the hot flush paper diary as they occurred during the day and night.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary.
Day 7 Change from Day -1
|
-2.8 Hot flushes
Interval -4.5 to -1.0
|
-1.4 Hot flushes
Interval -3.4 to 0.6
|
-5.1 Hot flushes
Interval -7.0 to -3.2
|
-8.3 Hot flushes
Interval -10.2 to -6.4
|
-5.8 Hot flushes
Interval -7.9 to -3.8
|
|
Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary.
Day 14 Change from Day -1
|
-3.6 Hot flushes
Interval -4.9 to -2.2
|
-2.3 Hot flushes
Interval -3.8 to -0.8
|
-6.0 Hot flushes
Interval -7.5 to -4.5
|
-8.6 Hot flushes
Interval -10.0 to -7.1
|
-7.0 Hot flushes
Interval -8.6 to -5.4
|
SECONDARY outcome
Timeframe: Baseline (week-1) and weeks 1 , 2The number of NTAs secondary to hot flushes was the sum of the number of moderate and severe night-time hot flushes recorded the following morning (twice-daily hot flush diary) or recorded contemporaneously on the continuous diary.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary
Baseline (Week -1)
|
4.51 Night-time Awakenings
Standard Deviation 2.282
|
5.61 Night-time Awakenings
Standard Deviation 1.785
|
5.41 Night-time Awakenings
Standard Deviation 2.337
|
4.74 Night-time Awakenings
Standard Deviation 2.111
|
4.76 Night-time Awakenings
Standard Deviation 1.443
|
|
Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary
Change from Week -1 to Week 1
|
-0.77 Night-time Awakenings
Standard Deviation 2.066
|
-0.80 Night-time Awakenings
Standard Deviation 2.448
|
-2.52 Night-time Awakenings
Standard Deviation 2.604
|
-2.75 Night-time Awakenings
Standard Deviation 2.335
|
-2.07 Night-time Awakenings
Standard Deviation 1.833
|
|
Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary
Change from Week -1 to Week 2
|
-1.44 Night-time Awakenings
Standard Deviation 2.128
|
-1.12 Night-time Awakenings
Standard Deviation 2.665
|
-3.00 Night-time Awakenings
Standard Deviation 2.751
|
-3.83 Night-time Awakenings
Standard Deviation 2.008
|
-3.02 Night-time Awakenings
Standard Deviation 2.117
|
SECONDARY outcome
Timeframe: baseline (day-1) to day 1 and day 7, pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours)Change in Luteinizing Hormone(LH) AUC from time zero to 8 hours. Pre-dose samples for LH were taken within 30 minutes prior to dose administration.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 Participants
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 Participants
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
150 mg BAY3427080
n=15 Participants
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
300 mg BAY3427080
n=13 Participants
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8)
Day -1
|
295.4 h*U/L
Standard Deviation 82.64
|
295.5 h*U/L
Standard Deviation 85.22
|
290.8 h*U/L
Standard Deviation 85.83
|
309.5 h*U/L
Standard Deviation 104.38
|
261.1 h*U/L
Standard Deviation 65.53
|
|
Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8)
Change from Day -1 to Day 1
|
14.4 h*U/L
Standard Deviation 31.33
|
4.7 h*U/L
Standard Deviation 35.80
|
-10.0 h*U/L
Standard Deviation 21.90
|
-31.1 h*U/L
Standard Deviation 38.28
|
-24.6 h*U/L
Standard Deviation 32.36
|
|
Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8)
Change from Day -1 to Day 7
|
12.4 h*U/L
Standard Deviation 57.46
|
22.9 h*U/L
Standard Deviation 37.07
|
10.2 h*U/L
Standard Deviation 20.49
|
-12.1 h*U/L
Standard Deviation 47.30
|
-4.4 h*U/L
Standard Deviation 33.43
|
Adverse Events
150 mg BAY3427080
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
50 mg BAY3427080
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
100 mg BAY3427080
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
300 mg BAY3427080
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
150 mg BAY3427080
n=15 participants at risk
150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days
|
Placebo Comparator
n=18 participants at risk
Placebo to match BAY3427080 (NT-814) capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
|
50 mg BAY3427080
n=15 participants at risk
50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
100 mg BAY3427080
n=15 participants at risk
100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
300 mg BAY3427080
n=13 participants at risk
300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
5.6%
1/18 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
7.7%
1/13 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
23.1%
3/13 • Number of events 3 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
11.1%
2/18 • Number of events 2 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
7.7%
1/13 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 2 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
5.6%
1/18 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
7.7%
1/13 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
General disorders
Catheter site related reaction
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
General disorders
Malaise
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
5.6%
1/18 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
7.7%
1/13 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
General disorders
Medical device site erythema
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
General disorders
Medical device site irritation
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
5.6%
1/18 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
7.7%
1/13 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
General disorders
Medical device site pruritus
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Infections and infestations
Otitis externa
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
5.6%
1/18 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
23.1%
3/13 • Number of events 3 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
7.7%
1/13 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
13.3%
2/15 • Number of events 2 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Investigations
Blood pressure increased
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
5.6%
1/18 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
5.6%
1/18 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
16.7%
3/18 • Number of events 3 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
33.3%
5/15 • Number of events 5 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
46.2%
6/13 • Number of events 6 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Nervous system disorders
Somnolence
|
33.3%
5/15 • Number of events 5 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
16.7%
3/18 • Number of events 3 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
33.3%
5/15 • Number of events 5 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
13.3%
2/15 • Number of events 2 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
69.2%
9/13 • Number of events 11 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
7.7%
1/13 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
5.6%
1/18 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
11.1%
2/18 • Number of events 2 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
20.0%
3/15 • Number of events 3 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
7.7%
1/13 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
5.6%
1/18 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
7.7%
1/13 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
33.3%
5/15 • Number of events 5 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
27.8%
5/18 • Number of events 5 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
13.3%
2/15 • Number of events 2 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
40.0%
6/15 • Number of events 6 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
15.4%
2/13 • Number of events 2 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
5.6%
1/18 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/18 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/15 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
6.7%
1/15 • Number of events 1 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
0.00%
0/13 • Adverse events data were collected on or after first drug administration up to end of study (Day 21).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI is required to postpone communication of results until a joint, multicenter publication of the multicenter study has occurred, or the sponsor confirms that no joint publication will be prepared, or 18 months since completion of the data analysis have passed. The sponsor can review planned publications for up to 60 days and request reasonable amendments. The review period can be extended by up to 6 months in case a patent application is planned.
- Publication restrictions are in place
Restriction type: OTHER