HealthyPhase 1NCT02448004

Study to Assess the Absorption, Metabolism and Excretion of 14C-JNJ-63623872 After a Single Dose in Healthy Male Participants

A Phase 1 study testing JNJ-63623872 in people with Healthy, run by Janssen Cilag N.V./S.A. at 1 site in Netherlands.

Completed

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

Trial summary

The primary objective of this study is to characterize the absorption and metabolic pathways of JNJ-63623872, and the excretion of the compound and its metabolites, after single oral dosing of 14C-JNJ-63623872 in healthy adult male participants. Read more about this study

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: JNJ-63623872
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteNetherlands
Study dates: 11 May 2015to 24 Jun 2015
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 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Participants must agree to comply with contraceptive measures as mentioned in protocol
Must be non-smokers for at least 3 months prior to screening
Must have a Body Mass Index (BMI; weight in kilogram divided by the square of height in meters) of 18.0 to 30.0 kilogram/meter square, extremes included
Must have signed an Informed consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study before starting any screening activities
Must be willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
Must have a normal 12-lead ECG (based on the mean value of the triplicate parameters) at screening and on Day 1 predose including: 1). normal sinus rhythm (heart rate between 45 and 100 beats per minute [bpm], extremes included); 2). QT interval corrected for heart rate according to Fridericia (QTcF) interval less than or equal to (<=) 450 milliseconds (ms); 3). QRS interval lower than 120 ms; 4). PR interval <= 220 ms

Who cannot join

Participants with a past history of heart arrhythmias (extrasystoli clinically significant in the opinion of the investigator, tachycardia at rest) or of risk factors for Torsade de Pointes syndrome
Participants with more than one episode of constipation (less than 1 stool per 3 days) during the last 2 months, or more than one episode of diarrhea (3 or more stools per day) during the last 2 months
Participants with a history of or a reason to believe the subject has a history of drug or alcohol abuse within the past 5 years
Participants having a positive urine drug test at study screening or on Day -1. Urine will be tested for the presence of amphetamines, benzodiazepines, cocaine, cannabinoids, opioids, methadone and barbiturates
Participants with documented human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at study screening
Participants with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M ([IgM]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen [HbsAg]), or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at study screening

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Study site
Groningen

Other trials in Netherlands

About this study

Official title: A Phase 1, Open-label Study to Characterize the Absorption, Metabolism and Excretion of 14C-JNJ-63623872 After a Single Dose in Healthy Male Subjects

Read the detailed description

This is a Phase 1, open-label (all people know the identity of the intervention), single dose study in 6 healthy adult male participants to characterize the absorption, metabolism and excretion of 14C-JNJ-63623872. The total study duration will be approximately of 16 days per participant. The study consists of 3 parts: Screening (that is, 28 days before study commences on Day 1); open-Label Treatment Phase(that is, Day 1); and Follow-up (that is, up to Day 16). All the eligible participants will receive 14C-JNJ-63623872 at a dose level of 600 milligram. Participants will enter the study site on Day -1 and stay at the study site at least until Day 8. Urine, feces, whole blood samples, plasma, nasal mucus and saliva samples will be collected up to Day 8. Unchanged JNJ-63623872 will be determined in plasma and, if feasible, in saliva. Participants' safety will be monitored throughout the study.

Conditions: Healthy
Being tested: JNJ-63623872
Keywords: Healthy, JNJ-63623872, 14C-JNJ-63623872

What participants receive

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

JNJ-63623872Drug
Also called 14C-JNJ-63623872
Participants will receive a single 600-mg dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872.

Study groups in NCT02448004
Study group	Role	What they receive
JNJ-63623872	Experimental	Participants will receive a single 600-milligram (mg) dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872. Receives: Drug: JNJ-63623872

What is being measured

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

Maximum Plasma Concentration (Cmax) of JNJ-63623872
The Cmax is the maximum plasma concentration.
Measured: Baseline up to Day 8
Time to reach maximum concentration (tmax) of JNJ-63623872
The Tmax is time to reach the maximum plasma concentration.
Measured: Baseline up to Day 8
Area Under the Plasma Concentration-Time Curve From Time Zero to Last (AUC [0-last]) of JNJ-63623872
AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
Measured: Baseline up to Day 8
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-63623872
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; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Measured: Baseline up to Day 8
Terminal Half-Life(t[1/2]) of JNJ-63623872
Terminal half-life (t[(1/2]) is defined as 0.693/Lambda(z).
Measured: Baseline up to Day 8
Rate Constant (Lambda[z])
Lambda(z) is first-order 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: Baseline up to Day 8
Apparent total body clearance (CL/F) of JNJ-63623872
Clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The CL/F will be calculated by dividing the dose by AUC (0-infinity).
Measured: Baseline up to Day 8
Apparent volume of distribution at the terminal Phase (Vd[z] /F) of JNJ-63623872
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.The Vd(z)/F will be calculated by dividing CL/F by lambda(z).
Measured: Baseline up to Day 8
Amount of JNJ-63623872 excreted in Urine (Ae[x-y])
Amount excreted into urine over a given time interval, calculated from the urinary drug concentration of the collection interval x to y hours post dosing multiplied with the associated urine volume of the interval.
Measured: Baseline up to Day 8
Total Amount of JNJ-63623872 excreted in Urine (Ae[total])
Total amount excreted into urine, calculated by adding the amounts of the individual intervals together.
Measured: Baseline up to Day 8
Percentage of JNJ-63623872 dose excreted into urine
Percentage of the dose excreted into urine of the collection interval x to y hours post dosing, calculated as 100 x (Aex-y/Dose).
Measured: Baseline up to Day 8
Total Percentage of JNJ-63623872 dose excreted into urine
Total percentage of the dose excreted into urine, calculated as 100 * (Ae[total]/Dose).
Measured: Baseline up to Day 8
Renal clearance
Renal clearance calculated as Ae (total)/AUC (infinity).
Measured: Baseline up to Day 8

Timeline

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

11 May 201524 Jun 2015

First posted19 May 2015 (estimated)
Study start11 May 2015
Primary completion24 Jun 2015
Study completion24 Jun 2015

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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02448004
Sponsor's protocol ID: CR107301
Other IDs: 63623872FLZ1007, 2015-000719-42, 2015
Status last verified: Jun 2017
First submitted: 15 May 2015
Last updated: 2 Jul 2017
Results posted: No
Data monitoring committee: No
FDA-regulated device: 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?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label Study to Characterize the Absorption, Metabolism and Excretion of 14C-JNJ-63623872 After a Single Dose in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02448004
Acronym / sponsor ID: CR107301
Conditions: Healthy
Keywords: Healthy, JNJ-63623872, 14C-JNJ-63623872
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Janssen Cilag N.V./S.A.Industry (pharma, biotech, devices)
Study start: 11 May 2015 (actual)
Primary completion: 24 Jun 2015 (actual)
Study completion: 24 Jun 2015 (actual)
First posted: 19 May 2015 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
JNJ-63623872	Experimental	Drug: JNJ-63623872Participants will receive a single 600-milligram (mg) dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872.

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Participants must agree to comply with contraceptive measures as mentioned in protocol
Must be non-smokers for at least 3 months prior to screening
Must have a Body Mass Index (BMI; weight in kilogram divided by the square of height in meters) of 18.0 to 30.0 kilogram/meter square, extremes included
Must have signed an Informed consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study before starting any screening activities
Must be willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures

Key exclusion criteria (6 listed)

Participants with a past history of heart arrhythmias (extrasystoli clinically significant in the opinion of the investigator, tachycardia at rest) or of risk factors for Torsade de Pointes syndrome
Participants with more than one episode of constipation (less than 1 stool per 3 days) during the last 2 months, or more than one episode of diarrhea (3 or more stools per day) during the last 2 months
Participants with a history of or a reason to believe the subject has a history of drug or alcohol abuse within the past 5 years
Participants having a positive urine drug test at study screening or on Day -1. Urine will be tested for the presence of amphetamines, benzodiazepines, cocaine, cannabinoids, opioids, methadone and barbiturates
Participants with documented human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at study screening

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-63623872Also: 14C-JNJ-63623872Participants will receive a single 600-mg dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872.	Drug	JNJ-63623872

Primary outcome

Maximum Plasma Concentration (Cmax) of JNJ-63623872
Time frame: Baseline up to Day 8
The Cmax is the maximum plasma concentration.
Time to reach maximum concentration (tmax) of JNJ-63623872
Time frame: Baseline up to Day 8
The Tmax is time to reach the maximum plasma concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last (AUC [0-last]) of JNJ-63623872
Time frame: Baseline up to Day 8
AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-63623872
Time frame: Baseline up to Day 8
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; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Terminal Half-Life(t[1/2]) of JNJ-63623872
Time frame: Baseline up to Day 8
Terminal half-life (t[(1/2]) is defined as 0.693/Lambda(z).
Rate Constant (Lambda[z])
Time frame: Baseline up to Day 8
Lambda(z) is first-order 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.
Apparent total body clearance (CL/F) of JNJ-63623872
Time frame: Baseline up to Day 8
Clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The CL/F will be calculated by dividing the dose by AUC (0-infinity).
Apparent volume of distribution at the terminal Phase (Vd[z] /F) of JNJ-63623872
Time frame: Baseline up to Day 8
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.The Vd(z)/F will be calculated by dividing CL/F by lambda(z).
Amount of JNJ-63623872 excreted in Urine (Ae[x-y])
Time frame: Baseline up to Day 8
Amount excreted into urine over a given time interval, calculated from the urinary drug concentration of the collection interval x to y hours post dosing multiplied with the associated urine volume of the interval.
Total Amount of JNJ-63623872 excreted in Urine (Ae[total])
Time frame: Baseline up to Day 8
Total amount excreted into urine, calculated by adding the amounts of the individual intervals together.
Percentage of JNJ-63623872 dose excreted into urine
Time frame: Baseline up to Day 8
Percentage of the dose excreted into urine of the collection interval x to y hours post dosing, calculated as 100 x (Aex-y/Dose).
Total Percentage of JNJ-63623872 dose excreted into urine
Time frame: Baseline up to Day 8
Total percentage of the dose excreted into urine, calculated as 100 * (Ae[total]/Dose).
Renal clearance
Time frame: Baseline up to Day 8
Renal clearance calculated as Ae (total)/AUC (infinity).

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 2 Jul 2017.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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 Cilag N.V./S.A., Belgium Clinical Trial study director

Janssen Cilag N.V./S.A.

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 in people with Healthy, run by Janssen Cilag N.V./S.A. 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 6 inclusion and 6 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 2 Jul 2017. 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?

Maximum Plasma Concentration (Cmax) of JNJ-63623872 (time frame: Baseline up to Day 8). The study lists 13 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 NCT02448004.

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 2 Jul 2017.