A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-53718678; Drug: JNJ-64417184

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: JNJ-53718678; JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.; Drug: JNJ-64417184; JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.
Experimental: Treatment Sequence 2: Treatment BCA; Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment A in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.	Drug: JNJ-53718678; JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.; Drug: JNJ-64417184; JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.
Experimental: Treatment Sequence 3: Treatment CAB; Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment B in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.	Drug: JNJ-53718678; JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.; Drug: JNJ-64417184; JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.
Experimental: Treatment Sequence 4: Treatment ACB; Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment B in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.	Drug: JNJ-53718678; JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.; Drug: JNJ-64417184; JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.
Experimental: Treatment Sequence 5: Treatment BAC; Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment C in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.	Drug: JNJ-53718678; JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.; Drug: JNJ-64417184; JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.
Experimental: Treatment Sequence 6: Treatment CBA; Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment A in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.	Drug: JNJ-53718678; JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.; Drug: JNJ-64417184; JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed Plasma Analyte Concentration (Ctrough) of JNJ-53718678	Ctrough is defined as observed plasma analyte concentration just prior to the beginning of a dosing interval.	Day 2, 3, 4, 5 and 6: predose; Day 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose
Ctrough of JNJ-64417184	Ctrough is defined as observed plasma analyte concentration just prior to the beginning of a dosing interval.	Day 2, 3, 4, 5 and 6: predose; Day 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-53718678	Cmax is defined as maximum observed plasma analyte concentration.	Day 1 and 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose
Cmax of JNJ-64417184	Cmax is defined as maximum observed plasma analyte concentration.	Day 1 and 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose
Area Under the Plasma Concentration-time Curve from Time of Administration up to 24 Hours Postdose (AUC[24h]) of JNJ-53718678	AUC24h is defined as AUC from time 0 to 24 hours postdose.	Up to 24 hours postdose
AUC24h of JNJ-64417184	AUC24h is defined as AUC from time 0 to 24 hours postdose.	Up to 24 hours postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 42 days

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CR108693; 2019-002695-13 (EudraCT Number); 64417184RSV1003 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No