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

• Status: Completed
• Trial end date: 2015-10-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the antiviral effect of repeated oral dosing of JNJ 53718678 compared to placebo in healthy adult participants infected through inoculation with respiratory syncytial virus (RSV)-A Memphis 37b virus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Sciences Ireland UC
• Treatments: Antiviral Agents

Criteria

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

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)