HealthyPhase 1NCT02658825

A Study to Evaluate the Effect of JNJ-63623872 on Cardiac Repolarization Interval in Healthy Participants

A Phase 1 study testing JNJ-63623872 2400 milligram (mg), JNJ-63623872 3000 mg and JNJ-63623872 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

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 JNJ-63623872 on the QT/QTc interval at supratherapeutic exposure in healthy participants (Panel 2). Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: JNJ-63623872 2400 milligram (mg), JNJ-63623872 3000 mg and JNJ-63623872
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteBelgium
Study dates: Jan 2016to Apr 2016
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Each participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
A female participant must agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the (last dose of) study drug
A male participant who is sexually active with a woman of childbearing potential must agree to use two effective methods of contraception during the study and for at least 90 days after receiving the (last dose of) study drug, and a male participant must also not donate sperm during the study and for at least 90 days after receiving the (last dose of) study drug
Participants must be non-smokers for at least 3 months prior to Screening
Participants must have a Body Mass Index (BMI) between 18.0 and 30.0 kilogram per meter^2 (kg/m^2) (inclusive) at Screening

Who cannot join

Participant has a history of 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, 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
Participants with a history of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardias, and heart blocks
Participants with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
Participants with electrolyte abnormalities (hypokalemia, hypocalcemia, hypomagnesemia) of grade 2 or above within 21 days prior to the (first) intake of the study drug
Participants with a breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues
Participant has taken any disallowed therapies (Concomitant Therapy) before the planned (first) intake of study drug
Participant has known allergies, hypersensitivity, or intolerance to JNJ-63623872, moxifloxacin or its excipients

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Study site
Antwerp

Other trials in Belgium

About this study

Official title: A Double-blind, Double-dummy, Randomized, 3-Period Cross-over, Placebo- and Positive-controlled Study to Evaluate the Effect of JNJ-63623872 on Cardiac Repolarization Interval in Healthy Subjects

The purpose of this study is to evaluate the effect of JNJ-63623872 on the QT/QTc interval at supratherapeutic exposure in healthy participants (Panel 2).

Read the detailed description

This is a two-part Phase 1 study consisting of a dose escalation part (Panel 1) and a thorough QT (TQT) part (Panel 2). Panel 1 will be a double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study medication assigned to participants by chance), placebo-controlled dose escalation study in healthy participants to determine the safety, tolerability and pharmacokinetics of JNJ-63623872 after administration of single doses of 2400 milligrams (mg) and 3000 mg under fasted conditions. The final dose to be used in the Panel 2 will be determined based on the results of this dose escalation part. An interim analysis will be conducted on Panel 1 to select the dose for Panel 2. Panel 2 will be a double-blind, double-dummy, randomized, 3-period crossover (the same medications provided to all participants but in different sequence), placebo- and positive controlled study to evaluate the effect of JNJ-63623872 on the QT/QTc interval in healthy participants. Participants' safety will be monitored throughout the study.

Conditions: Healthy
Being tested: JNJ-63623872 2400 milligram (mg), JNJ-63623872 3000 mg, JNJ-63623872, Moxifloxacin, Placebo (Matching with JNJ-63623872 2400 mg)
Keywords: Healthy, JNJ-63623872, Moxifloxacin

What participants receive

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

JNJ-63623872 2400 milligram (mg)Drug
Participants will receive JNJ-63623872 2400 mg tablet orally once on Day 1 of Panel 1.
JNJ-63623872 3000 mgDrug
Participants will receive JNJ-63623872 3000 mg tablet orally once on Day 1 of Panel 1.
JNJ-63623872Drug
Participants will receive JNJ-63623872 dose selected in Panel 1 tablet orally once on Day 1 of Panel 2.
MoxifloxacinDrug
Participants will receive moxifloxacin 400 mg capsule orally once on Day 1 of Panel 2.
Placebo (Matching with JNJ-63623872 2400 mg)Drug
Participants will receive placebo (matching with JNJ-63623872 2400 mg) tablet orally once on Day 1 of Panel 1.
Placebo (Matching with JNJ-63623872 3000 mg)Drug
Participants will receive placebo (matching with JNJ-63623872 3000 mg) tablet orally once on Day 1 of Panel 1 and 2.
Placebo (Matching with JNJ-63623872 Dose)Drug
Participants will receive placebo (matching with JNJ-63623872 dose) tablet orally once on Day 1 of Panel 2.
Placebo (Matching with Moxifloxacin)Drug
Participants will receive placebo (matching with Moxifloxacin) tablet orally once on Day 1 of Panel 2.

Study groups in NCT02658825
Study group	Role	What they receive
Panel 1: Dose level 1	Experimental	Participants will receive either treatment A (JNJ-63623872, 2400 milligram (mg) tablet orally once on Day 1) or treatment B [(placebo (matching with JNJ-63623872 2400 mg) tablet orally once on Day 1]. Receives: Drug: JNJ-63623872 2400 milligram (mg); Drug: Placebo (Matching with JNJ-63623872 2400 mg)
Panel 1: Dose level 2	Experimental	Participants will receive either treatment C (JNJ-63623872, 3000 mg tablet orally once on Day 1) or treatment D [placebo (matching with JNJ-63623872 3000 mg) tablet orally once on Day 1]. Receives: Drug: JNJ-63623872 3000 mg; Drug: Placebo (Matching with JNJ-63623872 3000 mg)
Panel 2: Treatment EFG	Experimental	Participants will receive treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 1; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 2; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period. Receives: Drug: JNJ-63623872; Drug: Moxifloxacin; Drug: Placebo (Matching with JNJ-63623872 Dose); Drug: Placebo (Matching with Moxifloxacin)
Panel 2: Treatment FGE	Experimental	Participants will receive treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 1; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 2; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period. Receives: Drug: JNJ-63623872; Drug: Moxifloxacin; Drug: Placebo (Matching with JNJ-63623872 Dose); Drug: Placebo (Matching with Moxifloxacin)
Panel 2: Treatment GEF	Experimental	Participants will receive treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 1; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 2; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 3. A washout period of 5 days will be maintained between each treatment period. Receives: Drug: JNJ-63623872; Drug: Moxifloxacin; Drug: Placebo (Matching with JNJ-63623872 Dose); Drug: Placebo (Matching with Moxifloxacin)
Panel 2: Treatment GFE	Experimental	Participants will receive treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 1; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 2; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period. Receives: Drug: JNJ-63623872; Drug: Moxifloxacin; Drug: Placebo (Matching with JNJ-63623872 Dose); Drug: Placebo (Matching with Moxifloxacin)
Panel 2: Treatment FEG	Experimental	Participants will receive treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 1; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 2; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period. Receives: Drug: JNJ-63623872; Drug: Moxifloxacin; Drug: Placebo (Matching with JNJ-63623872 Dose); Drug: Placebo (Matching with Moxifloxacin)
Panel 2: Treatment EGF	Experimental	Participants will receive treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 1; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 2; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 3. A washout period of 5 days will be maintained between each treatment period. Receives: Drug: JNJ-63623872; Drug: Moxifloxacin; Drug: Placebo (Matching with JNJ-63623872 Dose); Drug: Placebo (Matching with Moxifloxacin)

What is being measured

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

Change From Baseline in Corrected QT Interval (QTc) at Different Time Points
Electrocardiogram will be collected by Holter monitoring. The measured QT data will be corrected for heart rate using Fridericia (QTcF), Bazett (QTcB), and study-specific power (QTcP) correction methods. The QTcF as primary correction method.
Measured: 45, 30 and 15 minutes predose and 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose on Day 1

Secondary outcomes (9)

Maximum Observed Concentration (Cmax)
The Cmax is the maximum observed concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, Treatment C of Dose Level 2 (Panel 1) and Treatment E (Panel 2)
Time To Reach The Maximum Observed Concentration (Tmax)
The Tmax is the actual sampling time to reach the maximum observed concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, Treatment C of Dose Level 2 (Panel 1) and Treatment E (Panel 2)
Observed Concentration at 24 Hours Post Dosing (C24h)
The C24h is the observed concentration at 24 hours post dosing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUC[0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)
Area Under the Concentration Versus Time Curve (AUC) From Time of Administration up to 24 Hours Post Dosing (AUC24h)
The AUC24h is the area under the concentration versus time curve (AUC) from time of administration up to 24 hours post dosing.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 of Treatment E (Panel 2)
Elimination Rate Constant (Lambda[z])
Lambda (z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)
Apparent Terminal Elimination Half-life (t1/2term)
The T1/2term is the apparent terminal elimination half-life, calculated as 0.693/Lambda(z).
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)
Number of Participants with Adverse Events (AEs) and Serious AEs
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Screening up to Follow-up (10 to 14 days after last study drug administration)

Timeline

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

Jan 2016Apr 2016

First posted20 Jan 2016 (estimated)
Study startJan 2016
Primary completionApr 2016
Study completionApr 2016

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02658825
Sponsor's protocol ID: CR108108
Other IDs: 63623872FLZ1005, 2015-004365-82, 2015
Status last verified: Jan 2025
First submitted: 15 Jan 2016
Last updated: 3 Feb 2025
Results posted: No
Data monitoring committee: No

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 Double-blind, Double-dummy, Randomized, 3-Period Cross-over, Placebo- and Positive-controlled Study to Evaluate the Effect of JNJ-63623872 on Cardiac Repolarization Interval in Healthy Subjects
ClinicalTrials.gov ID: NCT02658825
Acronym / sponsor ID: CR108108
Conditions: Healthy
Keywords: Healthy, JNJ-63623872, Moxifloxacin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 20 Jan 2016 (estimated)
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.

The purpose of this study is to evaluate the effect of JNJ-63623872 on the QT/QTc interval at supratherapeutic exposure in healthy participants (Panel 2).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Panel 1: Dose level 1	Experimental	Drug: JNJ-63623872 2400 milligram (mg), Drug: Placebo (Matching with JNJ-63623872 2400 mg)Participants will receive either treatment A (JNJ-63623872, 2400 milligram (mg) tablet orally once on Day 1) or treatment B [(placebo (matching with JNJ-63623872 2400 mg) tablet orally once on Day 1].
Panel 1: Dose level 2	Experimental	Drug: JNJ-63623872 3000 mg, Drug: Placebo (Matching with JNJ-63623872 3000 mg)Participants will receive either treatment C (JNJ-63623872, 3000 mg tablet orally once on Day 1) or treatment D [placebo (matching with JNJ-63623872 3000 mg) tablet orally once on Day 1].
Panel 2: Treatment EFG	Experimental	Drug: JNJ-63623872, Drug: Moxifloxacin, Drug: Placebo (Matching with JNJ-63623872 Dose), Drug: Placebo (Matching with Moxifloxacin)Participants will receive treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 1; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 2; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period.
Panel 2: Treatment FGE	Experimental	Drug: JNJ-63623872, Drug: Moxifloxacin, Drug: Placebo (Matching with JNJ-63623872 Dose), Drug: Placebo (Matching with Moxifloxacin)Participants will receive treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 1; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 2; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period.
Panel 2: Treatment GEF	Experimental	Drug: JNJ-63623872, Drug: Moxifloxacin, Drug: Placebo (Matching with JNJ-63623872 Dose), Drug: Placebo (Matching with Moxifloxacin)Participants will receive treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 1; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 2; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 3. A washout period of 5 days will be maintained between each treatment period.
Panel 2: Treatment GFE	Experimental	Drug: JNJ-63623872, Drug: Moxifloxacin, Drug: Placebo (Matching with JNJ-63623872 Dose), Drug: Placebo (Matching with Moxifloxacin)Participants will receive treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 1; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 2; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period.
Panel 2: Treatment FEG	Experimental	Drug: JNJ-63623872, Drug: Moxifloxacin, Drug: Placebo (Matching with JNJ-63623872 Dose), Drug: Placebo (Matching with Moxifloxacin)Participants will receive treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 1; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 2; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period.
Panel 2: Treatment EGF	Experimental	Drug: JNJ-63623872, Drug: Moxifloxacin, Drug: Placebo (Matching with JNJ-63623872 Dose), Drug: Placebo (Matching with Moxifloxacin)Participants will receive treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 1; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 2; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 3. A washout period of 5 days will be maintained between each treatment period.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Each participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
A female participant must agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the (last dose of) study drug
A male participant who is sexually active with a woman of childbearing potential must agree to use two effective methods of contraception during the study and for at least 90 days after receiving the (last dose of) study drug, and a male participant must also not donate sperm during the study and for at least 90 days after receiving the (last dose of) study drug
Participants must be non-smokers for at least 3 months prior to Screening

Key exclusion criteria (7 listed)

Participant has a history of 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, 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
Participants with a history of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardias, and heart blocks
Participants with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
Participants with electrolyte abnormalities (hypokalemia, hypocalcemia, hypomagnesemia) of grade 2 or above within 21 days prior to the (first) intake of the study drug
Participants with a breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues

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-63623872 2400 milligram (mg)Participants will receive JNJ-63623872 2400 mg tablet orally once on Day 1 of Panel 1.	Drug	Panel 1: Dose level 1
JNJ-63623872 3000 mgParticipants will receive JNJ-63623872 3000 mg tablet orally once on Day 1 of Panel 1.	Drug	Panel 1: Dose level 2
JNJ-63623872Participants will receive JNJ-63623872 dose selected in Panel 1 tablet orally once on Day 1 of Panel 2.	Drug	Panel 2: Treatment EFG, Panel 2: Treatment EGF, Panel 2: Treatment FEG, Panel 2: Treatment FGE, Panel 2: Treatment GEF, Panel 2: Treatment GFE
MoxifloxacinParticipants will receive moxifloxacin 400 mg capsule orally once on Day 1 of Panel 2.	Drug	Panel 2: Treatment EFG, Panel 2: Treatment EGF, Panel 2: Treatment FEG, Panel 2: Treatment FGE, Panel 2: Treatment GEF, Panel 2: Treatment GFE
Placebo (Matching with JNJ-63623872 2400 mg)Participants will receive placebo (matching with JNJ-63623872 2400 mg) tablet orally once on Day 1 of Panel 1.	Drug	Panel 1: Dose level 1
Placebo (Matching with JNJ-63623872 3000 mg)Participants will receive placebo (matching with JNJ-63623872 3000 mg) tablet orally once on Day 1 of Panel 1 and 2.	Drug	Panel 1: Dose level 2
Placebo (Matching with JNJ-63623872 Dose)Participants will receive placebo (matching with JNJ-63623872 dose) tablet orally once on Day 1 of Panel 2.	Drug	Panel 2: Treatment EFG, Panel 2: Treatment EGF, Panel 2: Treatment FEG, Panel 2: Treatment FGE, Panel 2: Treatment GEF, Panel 2: Treatment GFE
Placebo (Matching with Moxifloxacin)Participants will receive placebo (matching with Moxifloxacin) tablet orally once on Day 1 of Panel 2.	Drug	Panel 2: Treatment EFG, Panel 2: Treatment EGF, Panel 2: Treatment FEG, Panel 2: Treatment FGE, Panel 2: Treatment GEF, Panel 2: Treatment GFE

Primary outcome

Change From Baseline in Corrected QT Interval (QTc) at Different Time Points
Time frame: 45, 30 and 15 minutes predose and 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose on Day 1
Electrocardiogram will be collected by Holter monitoring. The measured QT data will be corrected for heart rate using Fridericia (QTcF), Bazett (QTcB), and study-specific power (QTcP) correction methods. The QTcF as primary correction method.

9 secondary outcomes

Maximum Observed Concentration (Cmax)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, Treatment C of Dose Level 2 (Panel 1) and Treatment E (Panel 2)
Time To Reach The Maximum Observed Concentration (Tmax)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, Treatment C of Dose Level 2 (Panel 1) and Treatment E (Panel 2)
Observed Concentration at 24 Hours Post Dosing (C24h)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUC[0-infinity])
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)
Area Under the Concentration Versus Time Curve (AUC) From Time of Administration up to 24 Hours Post Dosing (AUC24h)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 of Treatment E (Panel 2)
Elimination Rate Constant (Lambda[z])
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)
Apparent Terminal Elimination Half-life (t1/2term)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)
Number of Participants with Adverse Events (AEs) and Serious AEs
Time frame: Screening up to Follow-up (10 to 14 days after last study drug administration)

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.

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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-63623872 2400 milligram (mg), JNJ-63623872 3000 mg and JNJ-63623872 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

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 6 inclusion and 7 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 Belgium. 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?

Change From Baseline in Corrected QT Interval (QTc) at Different Time Points (time frame: 45, 30 and 15 minutes predose and 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose on Day 1). 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 NCT02658825.

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; AzTrials last refreshed its copy on 6 Nov 2026.