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This study will investigate the effect of food and the effect of esomeprazole on the pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence ABC | Experimental | In Period 1 participants will receive 1 tablet of balovaptan after high-fat, high-calorie meal. In Period 2, after 12 to 21 days wash-out, participants will receive 1 tablet of balovaptan after 10-hour fast. In Period 3 participants will receive esomeprazole administered once daily for 6 days and with a single oral dose of balovaptan in the fasted state 1 hour after the fifth esomeprazole dose |
|
| Treatment sequence BAC | Experimental | In Period 1 participants will receive 1 tablet of balovaptan after 10-hour fast. In Period 2, after 12 to 21 days wash-out, participants will receive 1 tablet of balovaptan after high-fat, high-calorie meal. In Period 3 participants will receive esomeprazole administered once daily for 6 days and with a single oral dose of balovaptan in the fasted state 1 hour after the fifth esomeprazole dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balovaptan | Drug | Balovaptan will be administered after a high-fat, high-calorie meal (Treatment A), after a 10-hour fast (Treatment B), and after a 10-hour fast with esomeprazole 40 mg (Treatment C) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Balovaptan | Maximum plasma concentration of Balovaptan is estimated using non-compartmental methods. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Mean Area Under the Concentration-Time Curve From Time Extrapolated to Infinity (AUC (0-inf)) of Balovaptan | Area under the plasma concentration-time curve (time 0 to infinity) of Balovaptan is estimated using non-compartmental methods from the concentration-time profiles. Percent extrapolation less than or equal to 20% is required to obtain a reliable AUC0-inf. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC(0-24h)) of Balovaptan | Area under the plasma concentration-time curve of Balovaptan from time 0 to 24 hours post-dose is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post dose |
| Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Balovaptan | Area under the concentration-time curve (time 0 to time of last quantifiable concentration) of Balovaptan is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Time to Reach Cmax in Plasma (Tmax) of Balovaptan |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of M2 Metabolite | Maximum plasma concentration of M2 Metabolite is estimated using non-compartmental methods. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International Clinical Pharmacology Center (EDS US Clinic) | Lenexa | Kansas | 66219 | United States |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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Screening was conducted between Day -28 and Day -2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence ABC | Participants were randomized to ABC sequence on Day 1 of Period 1 with the treatments being as follows:
|
| FG001 | Treatment Sequence BAC | Participants were randomized to BAC sequence on Day 1 of Period 1 with the treatments being as follows:
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (6 Days) |
| |||||||||||||
| Wash-out Period (12- to 21-days) |
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| Treatment Period 2 (6 Days) |
| |||||||||||||
| Wash-out Period (12- to 21-days) |
| |||||||||||||
| Treatment Period 3 (6 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence ABC | Participants were randomized to ABC sequence on Day 1 of Period 1 with the treatments being as follows:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maximum Plasma Concentration (Cmax) of Balovaptan | Maximum plasma concentration of Balovaptan is estimated using non-compartmental methods. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
|
From baseline to end of study (up to approximately 7 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Balovaptan 20 mg Fed | Single oral doses of balovaptan 20 mg (1 × 20 mg tablet) were administered following consumption of a high-fat, high-calorie meal (Treatment A). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pain | Eye disorders | MedDRA version 22.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2019 | Dec 1, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000708839 | balovaptan |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Esomeprazole | Drug | Esomeprazole will be administered once daily for 6 days and with a single dose of balovaptan 1 hour after the fifth esomeprazole dose |
|
Time to maximum plasma concentration of Balovaptan is defined as first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units and estimated using non-compartmental methods from the concentration-time profiles.
| Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Last Quantifiable Concentration (Clast) of Balovaptan | Last quantifiable concentration is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Time To the Last Quantifiable Concentration (Tlast) of Balovaptan | Time to last quantifiable concentration is based on last detectable concentration in the time curve. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Time Between Dosing and Time of First Balovaptan Plasma Concentration (Tlag) | Time between dosing and time of first balovaptan plasma concentration is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Apparent Clearance (Cl/F) of Balovaptan | Apparent clearance is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Apparent Volume of Distribution (Vd/F) of Balovaptan | Apparent volume of distribution is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Terminal Elimination Phase Half-Life (T1/2) of Balovaptan | Terminal phase half-life expressed in time units is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Terminal Phase Rate Constant (λz) of Balovaptan | Terminal phase rate constant is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Plasma Concentrations of Balovaptan | Amount of Balovaptan in a given volume of plasma. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Maximum Plasma Concentration (Cmax) of M3 Metabolite | Maximum plasma concentration of M3 Metabolite is estimated using non-compartmental methods. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Maximum Plasma Concentration (Cmax) of Esomeprazole | Maximum plasma concentration of Esomeprazole is estimated using non-compartmental methods. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
| Area Under the Concentration-Time Curve From Time Extrapolated to Infinity (AUC (0-inf)) of M2 Metabolite | Area under the plasma concentration-time curve (time 0 to infinity) of M2 Metabolite is estimated using non-compartmental methods from the concentration-time profiles. Percent extrapolation less than or equal to 20% is required to obtain a reliable AUC0-inf. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Area Under the Concentration-Time Curve From Time Extrapolated to Infinity (AUC (0-inf)) of M3 Metabolite | Area under the plasma concentration-time curve (time 0 to infinity) of M3 Metabolite is estimated using non-compartmental methods from the concentration-time profiles. Percent extrapolation less than or equal to 20% is required to obtain a reliable AUC0-inf. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Area Under the Concentration-Time Curve From Time Extrapolated to Infinity (AUC (0-inf)) of Esomeprazole | Area under the plasma concentration-time curve (time 0 to infinity) of Esomeprazole is estimated using non-compartmental methods from the concentration-time profiles. Percent extrapolation less than or equal to 20% is required to obtain a reliable AUC0-inf. | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
| Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC(0-24h)) of M2 Metabolite | Area under the plasma concentration-time curve of M2 Metabolite from time 0 to 24 hours post-dose is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post dose |
| Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC(0-24h)) of M3 Metabolite | Area under the plasma concentration-time curve of M3 Metabolite from time 0 to 24 hours post-dose is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post dose |
| Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of M2 Metabolite | Area under the concentration-time curve (time 0 to time of last quantifiable concentration) of M2 Metabolite is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of M3 Metabolite | Area under the concentration-time curve (time 0 to time of last quantifiable concentration) of M3 Metabolite is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Esomeprazole | Area under the concentration-time curve (time 0 to time of last quantifiable concentration) of Esomeprazole is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
| Time to Reach Cmax in Plasma (Tmax) of M2 Metabolite | Time to maximum plasma concentration of M2 Metabolite is defined as first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units and estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Time to Reach Cmax in Plasma (Tmax) of M3 Metabolite | Time to maximum plasma concentration of M3 Metabolite is defined as first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units and estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Time to Reach Cmax in Plasma (Tmax) of Esomeprazole | Time to maximum plasma concentration of Esomeprazole is defined as first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units and estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
| Last Quantifiable Concentration (Clast) of M2 Metabolite | Last quantifiable concentration is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Last Quantifiable Concentration (Clast) of M3 Metabolite | Last quantifiable concentration is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Last Quantifiable Concentration (Clast) of Esomeprazole | Last quantifiable concentration is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
| Time To the Last Quantifiable Concentration (Tlast) of M2 Metabolite | Time to last quantifiable concentration is based on last detectable concentration in the time curve. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Time To the Last Quantifiable Concentration (Tlast) of M3 Metabolite | Time to last quantifiable concentration is based on last detectable concentration in the time curve. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Time To the Last Quantifiable Concentration (Tlast) of Esomeprazole | Time to last quantifiable concentration is based on last detectable concentration in the time curve. | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
| Terminal Elimination Phase Half-Life (T1/2) of M2 Metabolite | Terminal phase half-life expressed in time units is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Terminal Elimination Phase Half-Life (T1/2) of M3 Metabolite | Terminal phase half-life expressed in time units is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Terminal Elimination Phase Half-Life (T1/2) of Esomeprazole | Terminal phase half-life expressed in time units is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
| Percentage of Patricipants With Adverse Events (AEs) | Randomization to end of study (up to approximately 7 weeks) |
| Terminal Phase Rate Constant (λz) of M2 Metabolite | Terminal phase rate constant is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Terminal Phase Rate Constant (λz) of M3 Metabolite | Terminal phase rate constant is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Terminal Phase Rate Constant (λz) of Esomeprazole | Terminal phase half-life expressed in time units is estimated using non-compartmental methods from the concentration-time profiles. | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
| Plasma Concentrations of M2 Analyte | Amount of M2 Analyte in a given volume of plasma. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Plasma Concentrations of M3 Analyte | Amount of M3 Analyte in a given volume of plasma. | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
| Plasma Concentrations of Esomeprazole | Amount of Esomeprazole in a given volume of plasma. | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Treatment Sequence BAC | Participants were randomized to BAC sequence on Day 1 of Period 1 with the treatments being as follows:
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Single oral doses of balovaptan 20 mg (1 × 20 mg tablet) were after a ≥ 10 h fast (Treatment B)
| OG002 | Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted | Single oral doses of balovaptan 20 mg (1 × 20 mg tablet) were coadministered with esomeprazole 40 mg (Treatment C) in a fasted state |
|
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| Primary | Mean Area Under the Concentration-Time Curve From Time Extrapolated to Infinity (AUC (0-inf)) of Balovaptan | Area under the plasma concentration-time curve (time 0 to infinity) of Balovaptan is estimated using non-compartmental methods from the concentration-time profiles. Percent extrapolation less than or equal to 20% is required to obtain a reliable AUC0-inf. | For one participant with Balovaptan 20 mg Fasted+ Esomeprazole 40 mg Fasted, AUC(0-inf)%extrap was > 20%, so AUC(0-inf) and T1/2 were not included in summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
|
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| Primary | Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC(0-24h)) of Balovaptan | Area under the plasma concentration-time curve of Balovaptan from time 0 to 24 hours post-dose is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post dose |
|
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| Primary | Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Balovaptan | Area under the concentration-time curve (time 0 to time of last quantifiable concentration) of Balovaptan is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
|
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| Primary | Time to Reach Cmax in Plasma (Tmax) of Balovaptan | Time to maximum plasma concentration of Balovaptan is defined as first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units and estimated using non-compartmental methods from the concentration-time profiles. | Posted | Median | Full Range | h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
|
|
|
| Primary | Last Quantifiable Concentration (Clast) of Balovaptan | Last quantifiable concentration is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
|
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| Primary | Time To the Last Quantifiable Concentration (Tlast) of Balovaptan | Time to last quantifiable concentration is based on last detectable concentration in the time curve. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Primary | Time Between Dosing and Time of First Balovaptan Plasma Concentration (Tlag) | Time between dosing and time of first balovaptan plasma concentration is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Median | Full Range | h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Primary | Apparent Clearance (Cl/F) of Balovaptan | Apparent clearance is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Primary | Apparent Volume of Distribution (Vd/F) of Balovaptan | Apparent volume of distribution is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Primary | Terminal Elimination Phase Half-Life (T1/2) of Balovaptan | Terminal phase half-life expressed in time units is estimated using non-compartmental methods from the concentration-time profiles. | For one participant with Balovaptan 20 mg Fasted+ Esomeprazole 40 mg Fasted, AUC(0-inf)%extrap was > 20%, so AUC(0-inf) and T1/2 were not included in summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Maximum Plasma Concentration (Cmax) of M2 Metabolite | Maximum plasma concentration of M2 Metabolite is estimated using non-compartmental methods. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Maximum Plasma Concentration (Cmax) of M3 Metabolite | Maximum plasma concentration of M3 Metabolite is estimated using non-compartmental methods. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Maximum Plasma Concentration (Cmax) of Esomeprazole | Maximum plasma concentration of Esomeprazole is estimated using non-compartmental methods. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
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| Secondary | Area Under the Concentration-Time Curve From Time Extrapolated to Infinity (AUC (0-inf)) of M2 Metabolite | Area under the plasma concentration-time curve (time 0 to infinity) of M2 Metabolite is estimated using non-compartmental methods from the concentration-time profiles. Percent extrapolation less than or equal to 20% is required to obtain a reliable AUC0-inf. | For one participant (Balovaptan 20 mg Fasted, Balovaptan 20 mg Fasted + Esomeprazole) AUC(0-inf)%extrap was > 20%, so AUC(0-inf) was not included in summary statistics. For one participant in Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fastedthere was no terminal phase, so AUC(0-inf) could not be calculated. One participant was discontinued in Period 3 with Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted after withdrawal of consent. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Area Under the Concentration-Time Curve From Time Extrapolated to Infinity (AUC (0-inf)) of M3 Metabolite | Area under the plasma concentration-time curve (time 0 to infinity) of M3 Metabolite is estimated using non-compartmental methods from the concentration-time profiles. Percent extrapolation less than or equal to 20% is required to obtain a reliable AUC0-inf. | Balovaptan 20 mg Fed: 3 participants were exluded from the analysis due to AUC(0-inf)%extrap > 20% Balovaptan 20 mg Fasted: 3 participants were exluded from the analysis due to AUC(0-inf)%extrap > 20% Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted: 4 participants were exluded from the analysis due to AUC(0-inf)%extrap > 20%. One additional participant was discontinued in Period 3 with Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted after withdrawal of consent. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Area Under the Concentration-Time Curve From Time Extrapolated to Infinity (AUC (0-inf)) of Esomeprazole | Area under the plasma concentration-time curve (time 0 to infinity) of Esomeprazole is estimated using non-compartmental methods from the concentration-time profiles. Percent extrapolation less than or equal to 20% is required to obtain a reliable AUC0-inf. | 3 participants were excluded from the analysis due to missing data. For one of those the value was excluded due to AUC(0-inf)%extrap > 20%. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
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| Secondary | Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC(0-24h)) of M2 Metabolite | Area under the plasma concentration-time curve of M2 Metabolite from time 0 to 24 hours post-dose is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post dose |
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| Secondary | Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC(0-24h)) of M3 Metabolite | Area under the plasma concentration-time curve of M3 Metabolite from time 0 to 24 hours post-dose is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post dose |
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| Secondary | Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of M2 Metabolite | Area under the concentration-time curve (time 0 to time of last quantifiable concentration) of M2 Metabolite is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of M3 Metabolite | Area under the concentration-time curve (time 0 to time of last quantifiable concentration) of M3 Metabolite is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Esomeprazole | Area under the concentration-time curve (time 0 to time of last quantifiable concentration) of Esomeprazole is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
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| Secondary | Time to Reach Cmax in Plasma (Tmax) of M2 Metabolite | Time to maximum plasma concentration of M2 Metabolite is defined as first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units and estimated using non-compartmental methods from the concentration-time profiles. | Posted | Median | Full Range | h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Time to Reach Cmax in Plasma (Tmax) of M3 Metabolite | Time to maximum plasma concentration of M3 Metabolite is defined as first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units and estimated using non-compartmental methods from the concentration-time profiles. | Posted | Median | Full Range | h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Time to Reach Cmax in Plasma (Tmax) of Esomeprazole | Time to maximum plasma concentration of Esomeprazole is defined as first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units and estimated using non-compartmental methods from the concentration-time profiles. | Posted | Median | Full Range | h | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
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| Secondary | Last Quantifiable Concentration (Clast) of M2 Metabolite | Last quantifiable concentration is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Last Quantifiable Concentration (Clast) of M3 Metabolite | Last quantifiable concentration is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Last Quantifiable Concentration (Clast) of Esomeprazole | Last quantifiable concentration is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
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| Secondary | Time To the Last Quantifiable Concentration (Tlast) of M2 Metabolite | Time to last quantifiable concentration is based on last detectable concentration in the time curve. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Time To the Last Quantifiable Concentration (Tlast) of M3 Metabolite | Time to last quantifiable concentration is based on last detectable concentration in the time curve. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Time To the Last Quantifiable Concentration (Tlast) of Esomeprazole | Time to last quantifiable concentration is based on last detectable concentration in the time curve. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
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| Secondary | Terminal Elimination Phase Half-Life (T1/2) of M2 Metabolite | Terminal phase half-life expressed in time units is estimated using non-compartmental methods from the concentration-time profiles. | For one participant in Balovaptan 20 mg Fasted and one participant in Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted AUC(0-inf)%extrap was > 20%, so T1/2 were not included in summary statistics. For one additional participant in Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted there was no terminal phase, so AUC(0-inf) and T1/2 could not be calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Terminal Elimination Phase Half-Life (T1/2) of M3 Metabolite | Terminal phase half-life expressed in time units is estimated using non-compartmental methods from the concentration-time profiles. | For 3 subjects in Balovaptan 20 mg Fed, 3 subjects in Balovaptan 20 mg Fasted and 4 subjects in Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted AUC(0-inf)%extrap was > 20%, so AUC(0-inf) were not included in summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Terminal Elimination Phase Half-Life (T1/2) of Esomeprazole | Terminal phase half-life expressed in time units is estimated using non-compartmental methods from the concentration-time profiles. | For one participant AUC(0-inf)%extrap was > 20%, so T1/2 was not included in summary statistics. For 2 participants, there was no terminal phase, so T1/2 could not be calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
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| Secondary | Percentage of Patricipants With Adverse Events (AEs) | Posted | Count of Participants | Participants | Randomization to end of study (up to approximately 7 weeks) |
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| Primary | Terminal Phase Rate Constant (λz) of Balovaptan | Terminal phase rate constant is estimated using non-compartmental methods from the concentration-time profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | /h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Terminal Phase Rate Constant (λz) of M2 Metabolite | Terminal phase rate constant is estimated using non-compartmental methods from the concentration-time profiles. | For one participant there was no terminal phase, so they are excluded form the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | /h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Terminal Phase Rate Constant (λz) of M3 Metabolite | Terminal phase rate constant is estimated using non-compartmental methods from the concentration-time profiles. | For one participant there was no terminal phase, so they are excluded form the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | /h | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Terminal Phase Rate Constant (λz) of Esomeprazole | Terminal phase half-life expressed in time units is estimated using non-compartmental methods from the concentration-time profiles. | For two participants there was no terminal phase, so they are excluded form the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | /h | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
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| Primary | Plasma Concentrations of Balovaptan | Amount of Balovaptan in a given volume of plasma. | Number of analyzed participants reflects number of participants whose samples were available at given timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Plasma Concentrations of M2 Analyte | Amount of M2 Analyte in a given volume of plasma. | Number of analyzed participants reflects number of participants whose samples were available at given timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Plasma Concentrations of M3 Analyte | Amount of M3 Analyte in a given volume of plasma. | Number of analyzed participants reflects number of participants whose samples were available at given timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples at predose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, and 192 hours post dose |
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| Secondary | Plasma Concentrations of Esomeprazole | Amount of Esomeprazole in a given volume of plasma. | Number of analyzed participants reflects number of participants whose samples were available at given timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples at predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose |
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| 0 |
| 16 |
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Balovaptan 20 mg Fasted | Single oral doses of balovaptan 20 mg (1 × 20 mg tablet) were after a ≥ 10 h fast (Treatment B) | 0 | 16 | 0 | 16 | 1 | 16 |
| EG002 | Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted | Single oral doses of balovaptan 20 mg (1 × 20 mg tablet) were coadministered with esomeprazole 40 mg (Treatment C) in a fasted state. | 0 | 16 | 0 | 16 | 1 | 16 |
| Gastroenteritis | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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