A Phase 1, Open-label, Randomized, 3-way Crossover Study to Assess the Pharmacokinetic Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Subjects
- Conditions
- cold virusRespiratory syncytial virus10024970
- Registration Number
- NL-OMON48293
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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
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] <60 mL/min at screening, calculated by the Modification of Diet in
Renal Disease [MDRD] formula30), thyroid disease, neurologic or psychiatric
disease, infection, or any other illness that the investigator considers should
exclude the subject or that could interfere with the interpretation of the
study results.
2. Any laboratory abnormality >=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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the effect of single- and multiple-dose (once daily for 7 days)<br /><br>oral JNJ-64417184 on the PK of single- and multiple-dose (once daily for 7<br /><br>days) oral JNJ-53718678 when coadministered to healthy adult subjects under fed<br /><br>conditions.<br /><br><br /><br>To evaluate the effect of single- and multiple-dose (once daily for 7 days)<br /><br>oral JNJ-53718678 on the PK of single- and multiple-dose (once daily for 7<br /><br>days) oral JNJ-64417184 when coadministered to healthy adult subjects under fed<br /><br>conditions.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of single- and multiple-dose (once<br /><br>daily for 7 days) oral JNJ-64417184 and JNJ-53718678 when administered alone<br /><br>and in combination in healthy adult subjects under fed conditions.<br /><br><br /><br>.</p><br>