Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1295-4664 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this trial is to evaluate the effects of a single therapeutic and a single supra-therapeutic dose of BI 1015550 following oral administration on cardiac safety parameters in healthy male and female volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: H/M/P2/L/P1 | Experimental | 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 | Experimental | 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 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1015550 | Drug | BI 1015550 administered as low (L), and high (H), dose. Oral tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Maximum Mean Difference Between Moxifloxacin and Placebo in QTcF Changes From Baseline Between 20 Min to 24 Hours After Drug Administration. | 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. |
Not provided
Inclusion Criteria:
Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs - blood pressure (BP) and pulse rate (PR), 12-lead electrocardiogram (ECG), and clinical laboratory tests without any clinically significant abnormalities
Age of 18 to 50 years (inclusive)
Body mass index of 18.5 to 32 kg/m^2 (inclusive)
Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Either male subjects, or female subjects meet the following criteria requiring highly effective contraception from at least 30 days before the first administration of trial medication until 37 days after the last administration of the study drug:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Nottingham | NG11 6JS | United Kingdom |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
| FG009 | 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. |
| FG010 | 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. |
| FG011 | 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. |
| FG012 | 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. |
| FG013 | 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. |
| FG014 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treated in period 1 |
| |||||||||||||
| Treated in period 2 |
| |||||||||||||
| Treated in period 3 |
| |||||||||||||
| Treated in period 4 |
| |||||||||||||
| Treated in period 5 |
|
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | Milliseconds |
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo 1 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 18002430127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2024 | Oct 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2024 | Oct 30, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
This trial will be performed as a randomized, double-blind, 5-period crossover of BI 1015550 and moxifloxacin. Placebo will be given in two separate periods. There will be 15 treatment sequences based on a Prescott triple Latin square design for 5 treatments and 5 periods.
Not provided
Not provided
The administration of BI 1015550 and placebo will be blinded while the administration of moxifloxacin will be carried out open label.
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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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. |
|
|
| Moxifloxacin | Drug | Moxifloxacin was used as positive control, given as a high dose. Oral tablet. |
|
|
| Placebo | Drug | Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet. |
|
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. |
|
|
|
| Secondary | The Maximum Mean Difference Between Moxifloxacin and Placebo in QTcF Changes From Baseline Between 20 Min to 24 Hours After Drug Administration. | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | Milliseconds | 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. |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Placebo 2 | 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. | 0 | 46 | 0 | 46 | 4 | 46 |
| EG002 | Low-dose nerandomilast | 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. | 0 | 45 | 0 | 45 | 4 | 45 |
| EG003 | 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. | 0 | 45 | 0 | 45 | 3 | 45 |
| EG004 | High-dose moxifloxacin - Positive Control | 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. | 0 | 45 | 0 | 45 | 3 | 45 |
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.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |