Status:
COMPLETED
A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effect of single and multiple dose (once daily for 7 days) oral JNJ-64417184 and JNJ-53718678 on the pharmacokinetic (PK) of single and multiple-dose (once...
Eligibility Criteria
Inclusion
- Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2), extremes included, and body weight not less than (\<) 50 kg at screening
- 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 \[after the participant is supine for at least 5 minutes\], respiratory rate, and tympanic body temperature) performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, extremes included, and no higher than 90 mmHg diastolic at screening
- A normal 12-lead electrocardiogram (ECG; based on mean value of triplicate ECG parameters) at screening, consistent with normal cardiac conduction and function, including: (a) normal sinus rhythm (heart rate between 45 and 100 beats per minute \[bpm\], extremes included); (b) QT interval corrected for heart rate according to Fridericia (QTcF) less than or equal to (\<=) 450 milliseconds (ms) for male participants and \<=470 ms for female participants; (c) QRS interval \<120 ms; (d) PR interval \<=200 ms
- Female participant must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta hCG\]) pregnancy test at screening and on Day -1 of each treatment period
Exclusion
- 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 milliliter per minute (mL/min) at screening, calculated by the modification of diet in renal disease \[MDRD\] formula), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Past history of cardiac arrhythmias (example: extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example: hypokalemia, family history of long QT Syndrome)
- Any evidence of heart block or bundle branch block at screening
- History of human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection, or tests positive for HIV-1 or HIV-2 at screening
- Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04090086
Start Date
September 16 2019
End Date
December 10 2019
Last Update
February 3 2025
Active Locations (1)
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1
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, Netherlands, 9728 NZ