cold virus Respiratory syncytial virus
Conditions
Interventions
The study consists of 3 treatment periods. In each treatment period, subjects
will receive either JNJ-6441784 or JNJ 53718678 alone, or a combination of JNJ
64417184 and JNJ 53718678, once daily for
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, between 18 and 55 years of age, extremes included, at screening. 2. Body mass index (BMI; weight [kg]/height2 [m]2) between 18.0 and 30.0 kg/m2, extremes included, and body weight not less than 50 kg at screening. 3. Healthy on the basis of physical examination (including skin examination), medical and surgical history, and vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], and pulse rate [after the subject is supine for at least 5 minutes], respiratory rate, and oral body temperature) performed at screening. If there are abnormalities (not applicable for the parameters listed in inclusion criterion 5 [for blood pressure]), the subject may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the investigator. 4. Healthy on the basis of clinical laboratory tests performed at screening. If the results of the hematology, biochemistry, blood coagulation, or urinalysis are outside the normal reference ranges (not applicable for the parameters listed in exclusion criteria 1 and 2 [for laboratory parameters]), the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the investigator. 5. Blood pressure (after the subject is supine for 5 minutes) between 90 and 140 mmHg systolic, extremes included, and no higher than 90 mmHg diastolic at screening. Further criteria apply
Exclusion criteria
Exclusion criteria: 1. History of, or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (calculated creatinine clearance/estimated glomerular filtration rate [eGFR] =grade 1 (as defined by the Division of Acquired Immune Deficiency Syndrome [DAIDS] Table for Grading the Severity of Adult and Pediatric Adverse Events)9, considered to be clinically significant by the investigator at screening. 3. Past history of cardiac arrhythmias (eg, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome). 4. Any evidence of heart block or bundle branch block at screening. 5. History of human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection, or tests positive for HIV-1 or -2 at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of single- and multiple-dose (once daily for 7 days) oral JNJ-64417184 on the PK of single- and multiple-dose (once daily for 7 days) oral JNJ-53718678 when coadministered to healthy adult subjects under fed conditions. To evaluate the effect of single- and multiple-dose (once daily for 7 days) oral JNJ-53718678 on the PK of single- and multiple-dose (once daily for 7 days) oral JNJ-64417184 when coadministered to healthy adult subjects under fed conditions. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of single- and multiple-dose (once daily for 7 days) oral JNJ-64417184 and JNJ-53718678 when administered alone and in combination in healthy adult subjects under fed conditions. . | — |
Countries
Netherlands
Outcome results
None listed