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| Name | Class |
|---|---|
| Shionogi | INDUSTRY |
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This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baloxavir Marboxil 40 mg | Experimental |
| |
| Baloxavir Marboxil 80 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baloxavir Marboxil | Drug | Participants will receive either 40 mg or 80 mg of baloxavir marboxil on Day 1 as a single oral dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Baloxavir marboxil and baloxavir concentrations were analyzed by validated Liquid Chromatography with tandem mass spectrometry (LC-MS/MS). Non-compartmental analysis was employed to estimate the PK parameters. | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
| Time to Maximum Plasma Concentration (Tmax) | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
| Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
| Area Under the Concentration to Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
| Area Under the Concentration to Time Curve From Time 0 to Time t (AUC0-t) | Time t may be chosen as a time point where evaluable concentrations are available in at least 90% of participants. Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Up to Day 15 |
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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 |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35585696 | Derived | Retout S, De Buck S, Jolivet S, Duval V, Cosson V. A Pharmacokinetics-Time to Alleviation of Symptoms Model to Support Extrapolation of Baloxavir Marboxil Clinical Efficacy in Different Ethnic Groups with Influenza A or B. Clin Pharmacol Ther. 2022 Aug;112(2):372-381. doi: 10.1002/cpt.2648. Epub 2022 Jun 10. | |
| 35176206 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Baloxavir Marboxil 40 mg | Administered orally on Day 1 |
| FG001 | Baloxavir Marboxil 80 mg | Administered orally on Day 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baloxavir Marboxil 40 mg | Administered orally on Day 1 |
| BG001 | Baloxavir Marboxil 80 mg | Administered orally on Day 1 |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Maximum Plasma Concentration (Cmax) | Baloxavir marboxil and baloxavir concentrations were analyzed by validated Liquid Chromatography with tandem mass spectrometry (LC-MS/MS). Non-compartmental analysis was employed to estimate the PK parameters. | Only participants with quantifiable drug plasma concentrations were included in the parameter estimate. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
|
Baseline up to Day 15
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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 | Baloxavir Marboxil 40 mg | Administered orally on Day 1 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood bilirubin increased | Investigations | MedDRA Version 22.0 | Non-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 | Yes | No | No | Study Protocol | Jan 10, 2019 | Jun 2, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2020 | Jun 2, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000628402 | baloxavir |
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|
| Terminal Elimination Half-Life (T1/2) | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
| Apparent Total Oral Clearance (CL/F) | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
| Apparent Oral Volume of Distribution (Vz/F) | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
| Plasma Concentrations 24 (C24), 48 (C48), and 72 Hours (C72) Postdose | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | 24, 48 and 72 hours postdose |
| Liu Y, Retout S, Duval V, Jia J, Zou Y, Wang Y, Cosson V, Jolivet S, De Buck S. Pharmacokinetics, safety, and simulated efficacy of an influenza treatment, baloxavir marboxil, in Chinese individuals. Clin Transl Sci. 2022 May;15(5):1196-1203. doi: 10.1111/cts.13237. Epub 2022 Feb 19. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Administered orally on Day 1
|
|
| Primary | Time to Maximum Plasma Concentration (Tmax) | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Only participants with quantifiable drug plasma concentrations were included in the parameter estimate. | Posted | Median | Full Range | hours (h) | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
|
|
|
| Primary | Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Only participants with quantifiable drug plasma concentrations were included in the parameter estimate. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
|
|
|
| Primary | Area Under the Concentration to Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Only participants with quantifiable drug plasma concentrations were included in the parameter estimate. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
|
|
|
| Primary | Area Under the Concentration to Time Curve From Time 0 to Time t (AUC0-t) | Time t may be chosen as a time point where evaluable concentrations are available in at least 90% of participants. Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Only participants with quantifiable drug plasma concentrations were included in the parameter estimate. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
|
|
|
| Primary | Terminal Elimination Half-Life (T1/2) | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Only participants with quantifiable drug plasma concentrations were included in the parameter estimate. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours (h) | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
|
|
|
| Primary | Apparent Total Oral Clearance (CL/F) | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Only participants with quantifiable drug plasma concentrations were included in the parameter estimate. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters (L)/h | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
|
|
|
| Primary | Apparent Oral Volume of Distribution (Vz/F) | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Only participants with quantifiable drug plasma concentrations were included in the parameter estimate. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose |
|
|
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| Primary | Plasma Concentrations 24 (C24), 48 (C48), and 72 Hours (C72) Postdose | Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters. | Only participants with quantifiable drug plasma concentrations were included in the parameter estimate. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 24, 48 and 72 hours postdose |
|
|
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| Secondary | Percentage of Participants With Adverse Events (AEs) | Posted | Number | percentage of participants | Up to Day 15 |
|
|
|
| 16 |
| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | Baloxavir Marboxil 80 mg | Administered orally on Day 1 | 0 | 16 | 0 | 16 | 11 | 16 |
| Blood uric acid increased | Investigations | MedDRA Version 22.0 | Non-systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA Version 22.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 22.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 22.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 22.0 | Non-systematic Assessment |
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| Defect conduction intraventricular | Cardiac disorders | MedDRA Version 22.0 | Non-systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA Version 22.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 22.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA Version 22.0 | Non-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.
| Baloxavir |
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| Baloxavir C48 |
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| Baloxavir C72 |
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