Trial Outcomes & Findings for A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities (NCT NCT06107036)
NCT ID: NCT06107036
Last Updated: 2025-11-28
Results Overview
QT interval corrected for heart rate (using the method of Fridericia, QTcF) changes from baseline, measured between 20 minutes and 24 hours after drug administration, were analyzed using a linear Mixed Model for Repeated Measures (MMRM). Pairwise comparison was used to compare the QTcF changes for each dose of nerandomilast (e.g., low dose, high dose) with the placebo at every time point. Mean treatment differences in the QTcF changes from baseline at each time point were estimated by the differences in the corresponding least-squares means. Two-sided 90% confidence intervals based on the t-distribution were computed for each time point. The MMRM was adjusted for the discrete fixed effects treatment, period, time, the continuous fixed effects period- and participant-baseline, the fixed effect-by-time terms, participant as random effect and time within period as a repeated effect per participant. The covariance structure for the repeated effect time was unstructured.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
MMRM included measurements at these time points [hours:minutes] post-drug: 0:20, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 12:00, and 24:00. MMRM values at 12:00 (low dose) and 4:30 (high dose) are shown in the table below.
Results posted on
2025-11-28
Participant Flow
This randomized, placebo-controlled, double-blind (moxifloxacin: open-label), crossover study had 5 treatment periods separated by ≥7-day washouts. Treatments included a low dose nerandomilast \[L\], a high dose nerandomilast \[H\], a high dose moxifloxacin (positive control) \[M\]), and placebo \[P1, P2\]. The study assessed nerandomilast's effect on cardiac safety (QT/QTc interval) in healthy female and male participants across 15 sequences, each with 3 participants.
A total of 46 participants who met all inclusion and no exclusion criteria were enrolled in the study, and all completed the planned observation period per protocol. Participants could withdraw from the trial at any time. Two participants were partially excluded from the analysis: one due to a protocol deviation and the other due to the use of rescue medication.
Participant milestones
| Measure |
Sequence 1: H/M/P2/L/P1
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
|
Sequence 2: H/P1/L/P2/M
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
|
Sequence 3: H/L/P2/M/P1
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
|
Sequence 4: M/H/L/P1/P2
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
|
Sequence 5: M/P1/L/H/P2
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
|
Sequence 6: M/P2/H/L/P1
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
|
Sequence 7: P1/M/H/P2/L
Participants in this study received five treatments ordered as described below. Each treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours. Each treatment was separated by a wash-out period of at least 7 days.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
|
Sequence 8: P1/P2/H/M/L
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
|
Sequence 9: P1/L/M/H/P2
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
|
Sequence 10: P2/H/P1/M/L
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
|
Sequence 11: P2/P1/M/L/H
Participants in this study received five treatments ordered as described below. Each treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours. Each treatment was separated by a wash-out period of at least 7 days.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
|
Sequence 12: P2/L/M/P1/H
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
|
Sequence 13: L/H/P1/P2/M
Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
|
Sequence 14: L/M/P2/P1/H
Participants in this study received five treatments ordered as described below. Each treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours. Each treatment was separated by a wash-out period of at least 7 days.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
|
Sequence 15: L/P2/P1/H/M
Participants in this study received five treatments ordered as described below. Each treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours. Each treatment was separated by a wash-out period of at least 7 days.
L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treated in period 1
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
4
|
3
|
3
|
3
|
|
Treated in period 1
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
4
|
3
|
3
|
3
|
|
Treated in period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treated in period 2
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treated in period 2
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treated in period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treated in period 3
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treated in period 3
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treated in period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treated in period 4
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treated in period 4
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treated in period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treated in period 5
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treated in period 5
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treated in period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities
Baseline characteristics by cohort
| Measure |
All Participants
n=46 Participants
In this study, all participants received five treatments, administered in 15 different sequences. Each treatment was given orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment.
The treatments were as follows:
H (High-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast.
L (Low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast.
M (High-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin, which served as a positive control.
P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.
P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group.
|
|---|---|
|
Age, Continuous
|
36.9 Years
STANDARD_DEVIATION 8.8 • n=30 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: MMRM included measurements at these time points [hours:minutes] post-drug: 0:20, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 12:00, and 24:00. MMRM values at 12:00 (low dose) and 4:30 (high dose) are shown in the table below.Population: Electrocardiogram set (ECGS): This participant set includes all participants in the treated set who have at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which is not excluded due to ECG relevant important protocol deviations (iPDs). Such iPDs may be e.g., the use of pro-arrhythmic medications. Only participants with available ECG data were included.
QT interval corrected for heart rate (using the method of Fridericia, QTcF) changes from baseline, measured between 20 minutes and 24 hours after drug administration, were analyzed using a linear Mixed Model for Repeated Measures (MMRM). Pairwise comparison was used to compare the QTcF changes for each dose of nerandomilast (e.g., low dose, high dose) with the placebo at every time point. Mean treatment differences in the QTcF changes from baseline at each time point were estimated by the differences in the corresponding least-squares means. Two-sided 90% confidence intervals based on the t-distribution were computed for each time point. The MMRM was adjusted for the discrete fixed effects treatment, period, time, the continuous fixed effects period- and participant-baseline, the fixed effect-by-time terms, participant as random effect and time within period as a repeated effect per participant. The covariance structure for the repeated effect time was unstructured.
Outcome measures
| Measure |
Low-dose nerandomilast
n=43 Participants
Participants who received film-coated tablets containing a low dose of nerandomilast. The treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours.
|
High-dose nerandomilast
n=45 Participants
Participants received film-coated tablets containing a high dose of nerandomilast.
The treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
The Maximum Mean Difference Between Each Single Dose of Either a Low Dose or a High Dose of Nerandomilast and Placebo in QTcF Changes From Baseline Between 20 Min to 24 Hours After Drug Administration
|
3.0 Milliseconds
Interval 0.7 to 5.4
|
3.2 Milliseconds
Interval 1.2 to 5.2
|
SECONDARY outcome
Timeframe: MMRM included measurements at these time points [hours:minutes] post-drug: 0:20, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 12:00, and 24:00. MMRM values at 3:30 (high dose moxifloxacin) are shown in the table below.Population: Electrocardiogram set (ECGS): This participant set includes all participants in the treated set who have at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which is not excluded due to ECG relevant important protocol deviations (iPDs). Such iPDs may be e.g., the use of pro-arrhythmic medications. Only participants with available ECG data were included.
QT interval corrected for heart rate (using the method of Fridericia, QTcF) changes from baseline, measured between 20 minutes and 24 hours after drug administration, were analyzed using a linear Mixed Model for Repeated Measures (MMRM). Pairwise comparison was used to compare the QTcF changes for moxifloxacin with the placebo at every time point. Mean treatment differences in the QTcF changes from baseline at each time point were estimated by the differences in the corresponding least-squares means. Two-sided 90% confidence intervals based on the t-distribution were computed for each time point. The MMRM was adjusted for the discrete fixed effects treatment, period, time, the continuous fixed effects period- and participant-baseline, the fixed effect-by-time terms, participant as random effect and time within period as a repeated effect per participant. The covariance structure for the repeated effect time was unstructured.
Outcome measures
| Measure |
Low-dose nerandomilast
n=44 Participants
Participants who received film-coated tablets containing a low dose of nerandomilast. The treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours.
|
High-dose nerandomilast
Participants received film-coated tablets containing a high dose of nerandomilast.
The treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|
|
The Maximum Mean Difference Between Moxifloxacin and Placebo in QTcF Changes From Baseline Between 20 Min to 24 Hours After Drug Administration.
|
14.2 Milliseconds
Interval 12.4 to 16.1
|
—
|
Adverse Events
Placebo 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Low-dose nerandomilast
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
High-dose nerandomilast
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
High-dose moxifloxacin - Positive Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo 1
n=45 participants at risk
Participants who received placebo tablets designed to match the low-dose nerandomilast group. The treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Placebo 2
n=46 participants at risk
Participants who received placebo tablets designed to match the high-dose nerandomilast group. The treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours.
|
Low-dose nerandomilast
n=45 participants at risk
Participants who received film-coated tablets containing a low dose of nerandomilast. The treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours.
|
High-dose nerandomilast
n=45 participants at risk
Participants received film-coated tablets containing a high dose of nerandomilast.
The treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours.
|
High-dose moxifloxacin - Positive Control
n=45 participants at risk
Participants who received film-coated tablets containing a high dose of moxifloxacin as a positive control. The treatment was administered orally with 240 mL of water after an overnight fast of at least 10 hours.
Moxifloxacin was used as a positive control due to its modest QT-prolonging properties at a high dose level.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/45 • Adverse Events: up to 7 days following drug administration for placebo 1 and 2, low-dose nerandomilast, and high-dose nerandomilast, and for up to 4 days following administration of high-dose moxifloxacin. All-Cause Mortality: from the first drug administration on Day 1 until the end of the trial, up to a total of 44 days.
Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
|
8.7%
4/46 • Adverse Events: up to 7 days following drug administration for placebo 1 and 2, low-dose nerandomilast, and high-dose nerandomilast, and for up to 4 days following administration of high-dose moxifloxacin. All-Cause Mortality: from the first drug administration on Day 1 until the end of the trial, up to a total of 44 days.
Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
|
8.9%
4/45 • Adverse Events: up to 7 days following drug administration for placebo 1 and 2, low-dose nerandomilast, and high-dose nerandomilast, and for up to 4 days following administration of high-dose moxifloxacin. All-Cause Mortality: from the first drug administration on Day 1 until the end of the trial, up to a total of 44 days.
Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
|
6.7%
3/45 • Adverse Events: up to 7 days following drug administration for placebo 1 and 2, low-dose nerandomilast, and high-dose nerandomilast, and for up to 4 days following administration of high-dose moxifloxacin. All-Cause Mortality: from the first drug administration on Day 1 until the end of the trial, up to a total of 44 days.
Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
|
6.7%
3/45 • Adverse Events: up to 7 days following drug administration for placebo 1 and 2, low-dose nerandomilast, and high-dose nerandomilast, and for up to 4 days following administration of high-dose moxifloxacin. All-Cause Mortality: from the first drug administration on Day 1 until the end of the trial, up to a total of 44 days.
Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER