HealthyPhase 1NCT04090086

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

A Phase 1 study testing JNJ-53718678 and JNJ-64417184 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: JNJ-53718678 and JNJ-64417184
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteNetherlands
Study dates: 16 Sep 2019to 10 Dec 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

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

Other trials in Netherlands

About this study

Official title: 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: Healthy
Being tested: JNJ-53718678, JNJ-64417184

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JNJ-53718678Drug
JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.
JNJ-64417184Drug
JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.

Study groups in NCT04090086
Study group	Role	What they receive
Treatment Sequence 1: Treatment ABC	Experimental	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. Receives: Drug: JNJ-53718678; Drug: JNJ-64417184
Treatment Sequence 2: Treatment BCA	Experimental	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. Receives: Drug: JNJ-53718678; Drug: JNJ-64417184
Treatment Sequence 3: Treatment CAB	Experimental	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. Receives: Drug: JNJ-53718678; Drug: JNJ-64417184
Treatment Sequence 4: Treatment ACB	Experimental	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. Receives: Drug: JNJ-53718678; Drug: JNJ-64417184
Treatment Sequence 5: Treatment BAC	Experimental	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. Receives: Drug: JNJ-53718678; Drug: JNJ-64417184
Treatment Sequence 6: Treatment CBA	Experimental	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. Receives: Drug: JNJ-53718678; Drug: JNJ-64417184

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 hours postdose
AUC24h of JNJ-64417184
AUC24h is defined as AUC from time 0 to 24 hours postdose.
Measured: Up to 24 hours postdose

Secondary outcomes (1)

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.
Measured: Up to 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 201910 Dec 2019

First posted16 Sep 2019
Study start16 Sep 2019
Primary completion10 Dec 2019
Study completion10 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04090086
Sponsor's protocol ID: CR108693
Other IDs: 2019-002695-13, 64417184RSV1003, 2019
Status last verified: Jan 2025
First submitted: 13 Sep 2019
Last updated: 3 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04090086
Acronym / sponsor ID: CR108693
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 16 Sep 2019 (actual)
Primary completion: 10 Dec 2019 (actual)
Study completion: 10 Dec 2019 (actual)
First posted: 16 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment Sequence 1: Treatment ABC	Experimental	Drug: JNJ-53718678, Drug: JNJ-64417184Participants 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.
Treatment Sequence 2: Treatment BCA	Experimental	Drug: JNJ-53718678, Drug: JNJ-64417184Participants 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.
Treatment Sequence 3: Treatment CAB	Experimental	Drug: JNJ-53718678, Drug: JNJ-64417184Participants 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.
Treatment Sequence 4: Treatment ACB	Experimental	Drug: JNJ-53718678, Drug: JNJ-64417184Participants 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.
Treatment Sequence 5: Treatment BAC	Experimental	Drug: JNJ-53718678, Drug: JNJ-64417184Participants 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.
Treatment Sequence 6: Treatment CBA	Experimental	Drug: JNJ-53718678, Drug: JNJ-64417184Participants 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JNJ-53718678JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.	Drug	Treatment Sequence 1: Treatment ABC, Treatment Sequence 2: Treatment BCA, Treatment Sequence 3: Treatment CAB, Treatment Sequence 4: Treatment ACB, Treatment Sequence 5: Treatment BAC, Treatment Sequence 6: Treatment CBA
JNJ-64417184JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.	Drug	Treatment Sequence 1: Treatment ABC, Treatment Sequence 2: Treatment BCA, Treatment Sequence 3: Treatment CAB, Treatment Sequence 4: Treatment ACB, Treatment Sequence 5: Treatment BAC, Treatment Sequence 6: Treatment CBA

Primary outcome

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

1 secondary outcome

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 42 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Individual participant dataSharing planned: Yes. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-53718678 and JNJ-64417184 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observed Plasma Analyte Concentration (Ctrough) of JNJ-53718678 (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04090086.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.