NCT03502694

Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Oral Lumicitabine Regimens in Hospitalized Adult Participants Infected With Human Metapneumovirus

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Adult Subjects Infected With Human Metapneumovirus

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine in hospitalized adult participants infected with human metapneumovirus (hMPV - a virus closely related to respiratory syncytial virus (RSV) and has been identified as an important cause of acute respiratory infections, affecting all age groups) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal hMPV shedding using quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

Detailed description

The study consists of 3 phases: screening phase, treatment phase (Day 1 to Day 5/6 \[depending on timing of loading dose\]), and follow-up phase of 28 days post randomization. Participants will have assessments at Days 7, 10, 14, and 28 to evaluate safety, efficacy, and pharmacokinetics (PK). The primary hypothesis of study is a positive dose-response relationship of active treatment on average hMPV viral load area under concentration versus time curve (AUC) over 7 days, meaning that either average AUC on pooled active treatments is lower than on placebo, or average AUC on high active dose is lower than average AUC on placebo using multiple contrast testing. Based on review of PK, efficacy and safety data, Independent Data Monitoring Committee (IDMC) may recommend modifications to study design that is changes in dose and treatment duration.

Conditions

• Metapneumovirus

Interventions

Type	Name	Description
DRUG	Lumicitabine	Participants will receive loading dose and maintenance dose of lumicitabine tablets orally.
DRUG	Placebo	Participants will receive matching placebo tablets orally.

Timeline

• Start date: 2018-11-05
• Primary completion: 2019-04-30
• Completion: 2020-10-28
• First posted: 2018-04-19
• Last updated: 2018-11-15

Locations

112 sites across 16 countries: United States, Argentina, Australia, Brazil, Bulgaria, France, Japan, Malaysia, Netherlands, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study