Community Influenza

Phase 1

• Conditions: Influenza A; MedDRA version: 18.1Level: HLTClassification code 10022005Term: Influenza viral infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-004068-39-BE
• Lead Sponsor: janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-25
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 887

Inclusion Criteria

Part A:
• Willing and able to comply with nasopharyngeal swabs
• Subjects have an oral temperature of =38°C (100.4°F) within the prior 24 hours and at least 1 respiratory and 1 systemic symptom
Part B:
• Willing and able to comply with study requirements including treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
• Subjects have a documented oral temperature of =38°C (100.4°F) during the screening visit unless antipyretic medication had been administered within the past 6 hours, in which case a normal temperature at screening is acceptable, so long as the patient had a fever >38°C at some time prior to taking the medication, and at least 1 respiratory and 1 systemic symptom, both scored as at lease moderate” when self-assessed with a symptom assessment scale.
• The onset of flu-like symptoms must be =48 hours before receiving study drug.
• Subjects must be positive for influenza A with a rapid influenza diagnostic test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1050
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Any history of illness, comorbidity or lab abnormality, particularly pulmonary, cardiac or diabetes that might confound the results of the study or pose an additional risk in administering study drug to the subject.
• Use of a live attenuated intranasal spray vaccine(e.g. Flumist©) in the 3 weeks before study entry.
• Subjects who have taken antiviral medication, substrates of OATP1B1, OATP1B3, and strong inhibitors or inducers of CYP3A4, within 14 days before screening.
• Pregnant and nursing females, sexually active subjects or reproductive potential who are not willing to follow the contraception requirements.
• Subjects may not participate in an investigational study drug until the completion of this study.
• Subjects with bacterial infections requiring systemic antibacterial agents at the time of screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified