Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infectio

Phase 1

• Conditions: Respiratory Syncytial Virus; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 18.0 Level: HLT Classification code 10038717 Term: Respiratory syncytial viral infections System Organ Class: 100000004862

• Registration Number: EUCTR2014-005041-41-GB
• Lead Sponsor: Janssen Sciences Ireland UC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-12
• Study Completion: 2015-10-02
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 66

Inclusion Criteria

- Female participants must be of non-childbearing potential: postmenopausal for at least 2 years or surgically sterile or otherwise incapable of becoming pregnant
- Female participants, except for postmenopausal women, must have a negative serum pregnancy test at screening - Participants must agree to comply with contraceptive measures as mentioned in protocol
- Participants must be sero-suitable for respiratory syncytial virus (RSV) within 57 days prior to inoculation
- Participants must be non-smokers for at least one month prior to screening and participants must have a negative cotinine test at screening
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 74
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Participants with a past history of heart arrhythmias (extrasystoli, tachycardia at rest) or of risk factors for Torsade de Pointes syndrome - Participants with a history or evidence of abuse of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 3 months, which in the Investigator’s opinion would compromise participant’s safety and/or compliance with the study procedures
- Participants with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at screening
- Participants with current hepatitis A infection, or hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at screening
- Participants with active acute respiratory infection at admission (Study Day -1 or -2)

Study & Design

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