E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo in the prevention of influenza virus infection in subjects who are household members of influenza-infected patients. |
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E.2.2 | Secondary objectives of the trial |
- To determine the pharmacokinetics (PK) of the active form of baloxavir marboxil, in subjects treated with baloxavir marboxil for prophylaxis.
- To evaluate the safety of a single oral dose of baloxavir marboxil for prophylaxis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Index Patients:
- The first patient in a household with influenza virus infection in the 2018-2019 influenza season.
- Diagnosed as having influenza with positive rapid influenza diagnostic test (RIDT) by nasopharyngeal (if difficult, nasal or throat) swabs.
- Patients with onset of symptoms within 48 hours or less at informed consent.
- Patients who will receive any treatment with anti-influenza drugs.
- Patients with body weight of at least 10 kg at Screening.
Household Contacts:
- Subjects who had lived with the index patient for 48 hours or more prior to informed consent.
- Subjects who are judged not to have influenza virus infection by the investigator, have a body temperature (axillary) < 37.0°C, and have no influenza like symptoms.
- Women of childbearing potential who agree to use a highly effective method of contraception for 3 months after study drug administration. |
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E.4 | Principal exclusion criteria |
Household Contacts:
- Subjects who have been diagnosed with influenza during the 2018-2019 influenza season
- Subjects who are unable to live with the index patient from Screening until Day 10.
- Subjects who live with a household member who has any influenza like symptom(s) other than the index patient on the day of Screening.
- Subjects with household members other than the index patient that was diagnosed with or strongly suspected to have influenza during the 2018-2019 influenza season.
- Subjects who are immunocompromised |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects who are infected with influenza virus (RT-PCR positive), and present with fever and at least one respiratory symptom |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1 (baseline) to Day 10 |
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E.5.2 | Secondary end point(s) |
1) Time from study treatment to the time when fever, at least one respiratory symptom, and influenza virus infection were observed.
2) Proportion of subjects who are infected with influenza virus (RT-PCR positive), and present with fever or at least one influenza symptom
3) Time from study treatment to the time when fever or at least one influenza symptom, and influenza virus infection are observed.
4) Proportion of asymptomatic influenza-infected (RT-PCR positive) subjects
5) Proportion of subjects with influenza virus infection (RT-PCR positive)
6) Proportion of subjects with Adverse Events (AEs)
7) Maximum plasma concentration (Cmax) of S-033447
8) Area under the plasma concentration-time curve extrapolated from time zero to infinity (AUC0-inf) of S-033447
9) Plasma concentration 24 hours post-dose (C24) of S-033447 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Day 1 (baseline) to study end (approximately 15 days)
2) Day 1 (baseline) to Day 10
3) Day 1 (baseline) to study end (approximately 15 days)
4) Day 1 (baseline) to Day 10
5) Day 1 (baseline) to Day 10
6) Day 1 (baseline) to study end (approximately 15 days)
7) Day 1 (baseline) to study end (approximately 15 days)
8) Day 1 (baseline) to study end (approximately 15 days)
9) Day 1 (baseline) to 24 hours post-dose |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 5 |