A study to investigate the effects of lumicitabine (JNJ-64041575) in hospitalized adults infected with human metapneumovirus

Phase 1

• Conditions: Human metapneumovirus infection; MedDRA version: 20.0Level: PTClassification code 10066226Term: Metapneumovirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-001696-22-SE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-03
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

- Men or women =18 years old (or the legal age of consent in the jurisdiction in which the study is taking place), defined at the time of randomization.

- Subjects hospitalized (or in ER prior to hospitalization) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization.

- Subjects diagnosed with hMPV infection using a rapid PCR-based molecular diagnostic assay, with or without coinfection with another respiratory pathogen (respiratory virus or bacteria).

- Subjects who have an acute respiratory illness with signs and symptoms consistent with a viral infection (eg, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset =5 days from the anticipated time of randomization. As long as the underlying precipitant of the illness is considered by the investigator to be due to hMPV infection, the viral infection may present in one or more of the following ways:
• A lower respiratory tract infection, which may present in one of the following ways:
- Tracheobronchitis, defined as cough associated with rhonchi on lung auscultation and a clear chest imaging (eg, X-ray, computed tomography).
- Pneumonia, defined as acute respiratory symptoms occurring in a subject with a new pulmonary infiltrate on a radiological examination.
• Respiratory distress.
• Asthma exacerbation.
• COPD exacerbation.

- With the exception of the symptoms related to hMPV infection, subjects must be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population, and/or the hMPV infection. This determination must be recorded in the subject's source documents and initialed by the investigator.

- Subjects must be medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel or hematology are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal do not pose an unacceptable risk to the subject, are not clinically significant or are appropriate and reasonable for the population under study, and have no specific cut-off per the exclusion criteria. This determination must be recorded in the subject's source documents and initialed by the investigator. A single repeat laboratory evaluation is allowed for eligibility determination.

- Subjects (or their legally acceptable representative) must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

- A woman must have a negative urine pregnancy test (ß-human chorionic gonadotropin [ß-hCG]) 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 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 117

Exclusion Criteria

1. Subjects who are not expected to survive for more than 48 hours.
2. Subjects who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization.
3. Subjects who are considered by the investigator to be immunocompromised within the past 12 months, whether due to underlying medical condition (eg, malignancy or genetic disorder) or medical therapy (eg, medications other than corticosteroids for the treatment of COPD or asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant).
4. Subjects who have used systemic corticosteroids for >7 consecutive days immediately prior to randomization at doses higher than 20 mg/day of prednisone or equivalent.
5. Subjects who have taken any disallowed therapies as noted in Section 8, Prestudy and Concomitant Therapy before the planned first dose of study drug.
6. Subjects with a known history of human immunodeficiency virus (HIV) or chronic viral hepatitis.
7. Subjects with ALT =3x the upper limit of normal (ULN) AND bilirubin =2×ULN (direct >35%) OR ALT =5×ULN at screening.
8. Subjects with 1 or more of the following laboratory abnormalities at screening:
- Hemoglobin <9.5 g/dL
- Platelet count <75,000/mm3
- White blood cell count <1,000/mm³
- Absolute neutrophil count <1,000/mm³
9. Subjects undergoing peritoneal dialysis, hemodialysis, or hemofiltration or with an estimated glomerular filtration rate (GFR) (determined by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) of <60 mL/min/1.73m².
10. Subjects who have known allergies, hypersensitivity, or intolerance to lumicitabine or its excipients (refer to Investigator's Brochure).
11. Subjects unwilling to undergo mid-turbinate nasal swab procedures or with any physical abnormality which limits the ability to collect regular nasal specimens.
12. Subjects unable to take medications enterally or with a known gastrointestinal-related condition that is considered by the sponsor or investigator to be likely to interfere with study drug absorption.
13. Subjects who received prescription medications intended to prevent or treat the hMPV infection itself (eg, ribavirin, IV immunoglobulin), an investigational drug, an investigational vaccine, or used an invasive investigational medical device within 30 days or 5 half-lives (whichever is longer) before the planned first dose of study drug or are currently enrolled in an investigational study.
14. Subjects being treated with extracorporeal membrane oxygenation.
15. Women who are pregnant or breast-feeding.
16. Men who plan to father a child while enrolled in this study or within 104 days after the last dose of study drug.
17. Subjects with any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Study & Design

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