cold virus respiratory syncytial virus (RS-virus)
Conditions
Interventions
The study consists of 4 treatment periods. In each treatment period, the
volunteers will receive a single dose of 300 milligrams (mg) JNJ-6441784. The
meal regimen prior to administration of JNJ-644
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, 18 to 55 years of age, extremes included, at screening. 2. During the study (from the day of first study drug intake onwards) and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after the last study drug intake, a male subject must agree: • To wear a condom when engaging in any activity that allows for passage of ejaculate to another person (male subject should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak); • Not to donate sperm for the purpose of reproduction. Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for subjects participating in clinical studies. 3. Female subjects must be of non-childbearing potential defined as: • Postmenopausal A postmenopausal state is defined as no menses for >12 months without an alternative medical explanation. A high follicle stimulating hormone (FSH) level (>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormone replacement therapy. In the absence of >12 months of amenorrhea, 2 FSH measurements have to be available, measured at least 3 months apart, OR • Permanently sterile Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. 4. Must have a body mass index (BMI; weight [kg]/height2 [m2]) between 18.0 and 30.0 kg/m2, extremes included, and body weight not less than 50.0 kg at screening. 5. Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening. If there are abnormalities, the subject may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator. Further Criteria apply.
Exclusion criteria
Exclusion criteria: 1. Any evidence of heart block or bundle branch block at screening. 2. History of liver or renal dysfunction (calculated creatinine clearance/estimated glomerular filtration rate (eGFR)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To evaluate the effect of 45 different types of food conditions on the single dose PK of the JNJ184JNJ-64417184 tablet formulation administered orally, using the PK after a high fat meal as a reference, in healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To determine the PK parameters of JNJ-64417184 after a single dose. • To assess the safety and tolerability of JNJ-64417184 after a single dose when administered to healthy adult subjects. | — |
Countries
Netherlands
Outcome results
None listed