Dengue
Conditions
Interventions
Group 1 and 3:
Medication on Day 1, 2, 3, 10, 17 and 24
Group 2 and 4:
Medication on Day 1, 2, 3, 6, 10, 13, 17, 20, 24 and 27
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 55 years of age, extremes included, at the time of screening. 2. Healthy on the basis of physical examination, medical history (at screening only), and vital signs performed at screening and Day -1. If there are abnormalities, the participant 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 participant's source documents. 3. Healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, blood coagulation, hematology, or urinalysis are outside the normal reference ranges (except for those listed in the exclusion criteria), the participantmay be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents. 4. Body weight not less than 50 kg and body mass index (BMI; weight kg/height^2 m^2) within the range 18.0 and 30.0 kg/m^2, extremes included, at screening and Day -1. 5. Man or woman
Exclusion criteria
Exclusion criteria: 1. History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias (eg, extrasystole, tachycardia at rest) or other cardiac disease, risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome), 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 (creatinine clearance below 60 mL/min at screening, calculated by the Modification of Diet in Renal Disease [MDRD] formula, vascular, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), rheumatologic, neoplastic, endocrine, thyroid disease, neurologic or psychiatric disease, infection, metabolic disturbances, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results. 2. Participants with one or more of the following laboratory abnormalities at screening, as defined by the World Health Organization (WHO) Toxicity Grading Scale and in accordance with the normal ranges of the clinical laboratory if no gradings are available: - Serum creatinine elevation Grade 1 or greater (>=1.1×upper limit of normal [ULN]) - Hemoglobin lowering Grade 1 or greater (=1.25 ×ULN) - Total bilirubin Grade 1 or greater (>=1.1 ×ULN) - Any other laboratory toxicity Grade 2 or greater (for elevations of triglycerides, low-density lipoprotein (LDL) cholesterol, and/or total cholesterol: Grade 3 or greater). 3. Any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria. 4. Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients. 5. Has been dosed with JNJ-64281802 in past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the PK of JNJ-64281802 in healthy participants when administered in different multiple dose regimens and as different dose strengths. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of JNJ-64281802 in healthy participants when administered in different multiple dose regimens and as different dose strengths. | — |
Countries
Netherlands
Outcome results
None listed