| Primary | Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings | Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 14. | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Least Squares Mean | 90% Confidence Interval | ms | | Baseline (Predose Day 1), Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level B of Balovaptan | Participants received dose level of B balovaptan. | | OG001 | Placebo | Participants received placebo. |
| | | Title | Denominators | Categories |
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| Day 14 0.75 hours Pre-dose | - ParticipantsOG00052
- ParticipantsOG00152
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | LS Mean | 0.5 | Standard Error of the Mean | 1.47 | 2-Sided | 90 | -1.99 | 2.90 | | | | | Other | Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose | | | | |
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| Secondary | Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings | Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 1. | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Least Squares Mean | 90% Confidence Interval | ms | | Baseline (Predose Day 1), Day 1. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. | | OG001 | Placebo | Participants received placebo. |
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| Secondary | Change-From-Baseline QTcF of Balovaptan at Dose Level A Measurred on 12-Lead ECGs Extracted From Continuous Recordings | Change-from-baseline QTcF (ΔΔQTcF) at dose level A of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Days 1 and 14. | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Least Squares Mean | 90% Confidence Interval | ms | | Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Placebo | Participants received placebo. |
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| Secondary | Change-From-Baseline Heart Rate Measured on 12-Lead ECGs Extracted From Continuous Recordings | Change-from-baseline heart rate at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14. | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Least Squares Mean | 90% Confidence Interval | bpm | | Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. | | OG002 | Placebo | Participants received placebo. |
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| Secondary | Change-From-Baseline PR Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings | Change-from-baseline PR interval at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Day 1 and 14. | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Least Squares Mean | 90% Confidence Interval | ms | | Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. | | OG002 | Placebo | Participants received placebo. |
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| Secondary | Change-From-Baseline QRS Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings | Change-from-baseline QRS interval at dose level A and dose level B of balovapton measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14. | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Least Squares Mean | 90% Confidence Interval | ms | | Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. | | OG002 | Placebo | Participants received placebo. |
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| Secondary | Number of Categorical Outliers for QTcF | The number (percentage) of categorical outliers were participants who had increases in absolute QTcF values > 450 and ≤ 480 ms, > 480 and ≤ 500 ms, or > 500 ms. | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Count of Participants | | Participants | | Up to approximately 20 weeks | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. | | OG002 | Placebo | Participants received placebo. |
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| Secondary | Number of Categorical Outliers for HR | Number (percentage) of categorical outliers were participants with a decrease in HR from pre-dose baseline > 25% to a HR < 50 bpm; and increase in HR from pre-dose baseline > 25% to a HR > 100 bpm. | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Count of Participants | | Participants | | Up to approximately 20 weeks | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo. | | OG001 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG002 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. |
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| Secondary | Number of Categorical Outliers for PR | PR outliers criteria is as an increase of PR from baseline >25% resulting in PR >200 ms. | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Count of Participants | | Participants | | Up to approximately 20 weeks | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of Balovaptan | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. | | OG002 | Placebo | Participants received placebo. |
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| Secondary | Number of Categorical Outliers for QRS | QRS outlier criteria is an increase of QRS from baseline >25% resulting in QRS >120 ms. | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Count of Participants | | Participants | | Up to approximately 20 weeks | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | All participants received Treatment A and Treatment B and either Treatment C or Treatment D. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. | | OG002 | Placebo | Participants received placebo. |
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| Secondary | Number of Treatment Emergent Changes of T-Wave Morphology | Number (%) of participants falling into each of the T-wave categories: Normal (+), Flat, Notched (+), Biphasic, Normal (-), Notched (-). | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Count of Participants | | Participants | | Up to approximately 20 weeks | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. | | OG002 | Placebo | Participants received placebo. |
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| Secondary | Number of Treatment Emergent Changes of U-Wave Presence | Number (percentage) of participants with treatment emergent changes of U-wave presence. | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Count of Participants | | Participants | | Up to approximately 20 weeks | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. | | OG002 | Placebo | Participants received placebo. |
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| Secondary | Tmax of Balovaptan | | PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable). | Posted | | Median | Full Range | h | | Day 1 and Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. |
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| Secondary | Tmax of M2 Metabolite | | PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable). | Posted | | Median | Full Range | h | | Day 1 and Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. |
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| Secondary | Tmax M3 Metabolite | | PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable). | Posted | | Median | Full Range | h | | Day 1 and Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose Level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. |
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| Secondary | Cmax of Balovaptan | | PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable). | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 and Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. |
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| Secondary | Cmax of M2 Metabolite | | PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable). | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 and Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. |
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| Secondary | Cmax of M3 Metabolite | | PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable). | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 and Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of Balovaptan. |
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| Secondary | AUC0-24 of Balovaptan | | PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable). | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 1 and Day 14 (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. |
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| Secondary | AUC0-24 of M2 Metabolite | | PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable). | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 1 and Day 14 (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. |
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| Secondary | AUC0-24 of M3 Metabolite | | PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable). | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 1 and Day 14 (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. |
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| Secondary | Tmax of Moxifloxacin | | PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable). | Posted | | Median | Full Range | h | | Days 2 (Treatment C) or 15 (Treatment D). (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Treatment C | Participants in Treatment C received 400 mg of Moxifloxacin on Day 2. | | OG001 | Treatment D | Participants in Treatment D received 400 mg of Moxifloxacin on Day 15. |
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| Secondary | Cmax of Moxifloxacin | | PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable). | Posted | | Mean | Standard Deviation | ng/mL | | Days 2 (Treatment C) or 15 (Treatment D) (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Treatment C | Participants in Treatment C received 400 mg of Moxifloxacin on Day 2. | | OG001 | Treatment D | Participants in Treatment D received 400 mg of Moxifloxacin on Day 15. |
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| Secondary | AUC0-24 of Moxifloxacin | | PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable). | Posted | | Mean | Standard Deviation | h*ng/mL | | Days 2 (Treatment C) or 15 (Treatment D) (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Treatment C | Participants in Treatment C received 400 mg of moxifloxacin on Day 2. | | OG001 | Treatment D | Participants in Treatment D received 400 mg of moxifloxacin on Day 15. |
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| Secondary | Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentrations at Tmax of Balovaptan From Concentration-QTc Analysis | | PK/QTc population included all participants who were in both the QT/QTc and PK populations with at least 1 pair of post-dose PK and QTcF data from the same time point. | Posted | | Geometric Mean | 90% Confidence Interval | ms | | Baseline, Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose A of Balovaptan | Participants received dose A of Balovaptan. | | OG001 | Dose B of Balovaptan | Participants received dose B of balovaptan |
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| Secondary | Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentrations at Tmax of M2 From Concentration-QTc Analysis | | PK/QTc population included all participants who were in both the QT/QTc and PK populations with at least 1 pair of post-dose PK and QTcF data from the same time point. | Posted | | Geometric Mean | 90% Confidence Interval | ms | | Baseline, Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. |
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| Secondary | Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentration for M3 From Concentration-QTc Analysis | | PK/QTc population included all participants who were in both the QT/QTc and PK populations with at least 1 pair of post-dose PK and QTcF data from the same time point. | Posted | | Geometric Mean | 90% Confidence Interval | ms | | Baseline, Day 14. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Dose Level A of Balovaptan | Participants received dose level A of balovaptan. | | OG001 | Dose Level B of Balovaptan | Participants received dose level B of balovaptan. |
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| Secondary | Change-From-Baseline QTcF Measured on 12 Lead ECGs Extracted From Continuous Records | | QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value. | Posted | | Least Squares Mean | 90% Confidence Interval | ms | | Baseline, Day 15. (Each treatment period is 15 days.) | | | | ID | Title | Description |
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| OG000 | Moxifloxacin | Participants received 400 mg of moxifloxacin | | OG001 | Placebo | Participants received placebo. |
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| Secondary | Percentage of Participants With Treatment Emergent Adverse Events | | Groups C&D together are positive control to balovaptan. Moxifloxacin is given in a nested cross-over way using a joint placebo/positive control period, half subjects dosed with moxifloxacin on Day 2 and other half dosed on Day 15. | Posted | | Number | | Percentage of Participants | | Up to approximately 20 weeks. | | | | ID | Title | Description |
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| OG000 | Treatment Sequence A and B and Either C or D | All participants received Treatment A and Treatment B and either Treatment C or Treatment D. |
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