JNJ-64417184 / J&J - LARVOL DELTA

JNJ-7184, a Respiratory Syncytial Virus inhibitor targeting the connector domain of the viral polymerase. (PubMed, Antiviral Res) - "JNJ-7184 prevented RSV replication and transcription by inhibiting initiation or early elongation. JNJ-7184 was effective in air-liquid interface cultures and therapeutically in neonatal lambs, acting to drastically reverse the appearance of lung pathology."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Effect of Renal Impairment on JNJ-64417184 and Its Two Minor Metabolites JNJ-68294291 and JNJ-65201526 in Adult Participants (clinicaltrials.gov) - P1; N=6; Terminated; Sponsor: Janssen Pharmaceutica N.V., Belgium; N=36 ➔ 6; Trial completion date: Jul 2021 ➔ Nov 2020; Recruiting ➔ Terminated; Trial primary completion date: Jun 2021 ➔ Nov 2020; company decision

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Renal Disease

A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants (clinicaltrials.gov) - P1; N=14; Completed; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Completed

Clinical • Trial completion

A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants (clinicaltrials.gov) - P1; N=16; Completed; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Completed

Clinical • Trial completion

A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants (clinicaltrials.gov) - P1; N=14; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate the Effect of Renal Impairment on JNJ-64417184 and Its Two Minor Metabolites JNJ-68294291 and JNJ-65201526 in Adult Participants (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Janssen Pharmaceutica N.V., Belgium; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Renal Disease

A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants (clinicaltrials.gov) - P1; N=14; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P1 trial

A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Janssen Research & Development, LLC; N=32 ➔ 16

Clinical • Enrollment change

Advances in respiratory virus therapeutics - A meeting report from the 6th isirv Antiviral Group conference. (PubMed, Antiviral Res) - "Updates were presented on several influenza antivirals including baloxavir, CC-42344, VIS410, immunoglobulin, immune plasma, MHAA4549A, pimodivir (JNJ-63623872), umifenovir, and HA minibinders; RSV antivirals including presatovir (GS-5806), ziresovir (AK0529), lumicitabine (ALS-008176), JNJ-53718678, JNJ-64417184, and EDP-938; broad spectrum antivirals such as favipiravir, VH244, remdesivir, and EIDD-1931/EIDD-2801; and host directed strategies including nitazoxanide, eritoran, and diltiazem. Other topics included considerations of novel endpoints such as ordinal scales and patient reported outcomes (PRO), and study design issues, and other regulatory considerations for antiviral drug development. The aim of this report is to provide a summary of the presentations given at this meeting."

Journal • Review • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Effect of Renal Impairment on JNJ-64417184 and Its Two Minor Metabolites JNJ-68294291 and JNJ-65201526 in Adult Participants (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Janssen Pharmaceutica N.V., Belgium

Clinical • New P1 trial • Renal Disease

A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Janssen Research & Development, LLC; Trial completion date: Apr 2020 ➔ Aug 2020; Trial primary completion date: Apr 2020 ➔ Aug 2020

Clinical • Trial completion date • Trial primary completion date

A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants (clinicaltrials.gov) - P1; N=32; Completed; Sponsor: Janssen Research & Development, LLC; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants (clinicaltrials.gov) - P1; N=32; Active, not recruiting; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants (clinicaltrials.gov) - P1; N=32; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P1 trial

A First-In-Human Study of Orally Administered JNJ-64417184 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses, and the Antiviral Activity of Multiple Doses in a Respiratory Syncytial Virus (RSV) Challenge Study in Healthy Participants (clinicaltrials.gov) - P1; N=130; Completed; Sponsor: Janssen BioPharma, Inc.; Recruiting ➔ Completed

Trial completion • PCR

A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Participants (clinicaltrials.gov) - P1; N=16; Completed; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Completed

Trial completion

A Study in Healthy Volunteers to Assess the Effect of Different Types of Food on a Single-dose of JNJ-64417184 Administered as Tablets (clinicaltrials.gov) - P1; N=20; Completed; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Completed

Trial completion

A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants (clinicaltrials.gov) - P1; N=32; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P1 trial

A Study in Healthy Volunteers to Assess the Effect of Different Types of Food on a Single-dose of JNJ-64417184 Administered as Tablets (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Participants (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study in Healthy Volunteers to Assess the Effect of Different Types of Food on a Single-dose of JNJ-64417184 Administered as Tablets (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P1 trial

A Study to Assess the Relative Oral Bioavailability and Food Effect of Single-dose of JNJ-64417184 in Healthy Participants (clinicaltrials.gov) - P1; N=18; Completed; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Completed

Clinical • Trial completion

A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Participants (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P1 trial