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

Janssen Research & Development, LLC1 site in 1 country16 target enrollmentSeptember 16, 2019

ConditionsHealthy

InterventionsJNJ-53718678 JNJ-64417184

DrugsJNJ-53718678 JNJ-64417184

Overview

Phase: Phase 1
Intervention: JNJ-53718678
Conditions: Healthy
Sponsor: Janssen Research & Development, LLC
Enrollment: 16
Locations: 1
Primary Endpoint: Observed Plasma Analyte Concentration (Ctrough) of JNJ-53718678
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 daily for 7 days) oral JNJ 53718678 and JNJ-64417184, respectively when coadministered to healthy adult participants under fed conditions.

Registry

clinicaltrials.gov

Start Date

September 16, 2019

End Date

December 10, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Janssen Research & Development, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Arms & Interventions

Treatment Sequence 1: Treatment ABC

Participants will receive Treatment A (JNJ-53718678 once daily for 7 days) in Treatment Period 1, followed by Treatment B (JNJ-64417184 once daily for 7 days) in Treatment Period 2, followed by Treatment C (JNJ-53718678 once daily + JNJ-64417184 once daily for 7 days) in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.

Intervention: JNJ-53718678