HealthyPhase 1NCT02835508

Pharmacokinetic Study of JNJ-56021927 When Taken Orally as Tablet Formulation in Healthy Male Japanese Participants

A Phase 1 study testing JNJ-56021927 60 Milligram, JNJ-56021927 120 Milligram and JNJ-56021927 240 Milligram in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.

Completed

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

Official record

Search all trials

Trial summary

The purpose of the study is to assess the safety and Pharmacokinetic (PK) profile of JNJ-56021927 and its active metabolite JNJ-56142060 after single-dose administration of 60 milligram (mg), 120 mg, and 240 mg JNJ-56021927 as the tablet formulation in healthy male Japanese participants. Read more about this study

Who is it for?: Ages 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: JNJ-56021927 60 Milligram, JNJ-56021927 120 Milligram and JNJ-56021927 240 Milligram
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteJapan
Study dates: Jun 2016to Dec 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 20 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Participant must have a body mass index between 18.0 and 29.9 Kilogram per meter square (kg/m^2), inclusive, and a body weight not less than 50 Kilogram (kg)
Participant must have a blood pressure between 90 and 140 Millimeters of Mercury (mm Hg) systolic, inclusive, and no higher than 90 mm Hg diastolic at screening
Participant must have a normal 12-lead Electrocardiogram (ECG) (based on the mean value of the triplicate parameters) consistent with normal cardiac conduction and function at screening, including: a) normal sinus rhythm (heart rate between 45 and 90 beats per minute, extremes included); b) QT interval corrected for heart rate according to Fridericia (QTcF) <= 450 milliseconds (ms); c) QRS interval less than or equal (<=)110 ms; d) PR interval <200 ms; e) ECG morphology consistent with healthy cardiac conduction and function
Participant must be a healthy Japanese male
Participant must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during intercourse and to not donate sperm during the study and for 3 months after study drug administration

Who cannot join

Participant with 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
Participant has donated blood or blood product or had substantial loss of blood more than 200 milliliter (mL) within 1 month before study drug administration, or greater than equal (>=) 400 mL within 3 months before study drug administration, or participant has donated a total volume of blood in the past one year exceeding 1200 mL, or participant has an intention to donate blood or blood products during the study and for at least 2 months after completion of the study
Participant has presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc) or any medical condition that would affect sexual function
Participant has received an investigational drug including investigational vaccines or used an invasive investigational medical device within 3 months or within a period less than 10 times the drug's half-life, whichever is longer, before the planned study drug administration
Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-hepatitis C virus {HCV}) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Kumamoto

Other trials in Japan

About this study

Official title: A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Pharmacokinetic Profile of JNJ-56021927 When Administered as the Tablet Formulation in Healthy Male Japanese Subjects

Conditions: Healthy
Being tested: JNJ-56021927 60 Milligram, JNJ-56021927 120 Milligram, JNJ-56021927 240 Milligram

What participants receive

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

JNJ-56021927 60 MilligramDrug
Also called apalutamide
JNJ-56021927 60 mg oral tablet.
JNJ-56021927 120 MilligramDrug
Also called apalutamide
JNJ-56021927 120 mg as 2 tablets of 60 mg.
JNJ-56021927 240 MilligramDrug
Also called apalutamide
JNJ-56021927 240 mg as 4 tablets of 60 mg.

Study groups in NCT02835508
Study group	Role	What they receive
Treatment A	Experimental	Participants will receive a single dose of 1 tablet of JNJ-56021927, 60 milligram (mg) on Day 1. Receives: Drug: JNJ-56021927 60 Milligram
Treatment B	Experimental	Participants will receive a single dose of JNJ-56021927, 120 mg (2 tablets*60 mg) on Day 1. Receives: Drug: JNJ-56021927 120 Milligram
Treatment C	Experimental	Participants will receive a single dose of JNJ-56021927, 240 mg (4 tablets*60 mg) on Day 1. Receives: Drug: JNJ-56021927 240 Milligram

What is being measured

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

Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration (Cmax) will be assessed.
Measured: Predose, Up to Day 57
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Actual sampling time to reach maximum observed analyte concentration (Tmax) will be assessed.
Measured: Predose, Up to Day 57
Area Under Concentration from time zero to the last quantifiable AUC (0-last)
AUC from time zero to the last quantifiable concentration will be assessed.
Measured: Predose, Up to Day 57
Area Under the Plasma Concentration-Time Curve From Time Zero 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 (0-last) and C (0-last)/lambda(z); wherein AUC (0-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. AUC (0-infinity) will be assessed.
Measured: Predose, Up to Day 57
Time to Last Quantifiable Plasma Concentration (Tlast)
The Tlast, time to last observed quantifiable plasma concentration will be assessed.
Measured: Predose, Up to Day 57
Percentage of Area Under the Plasma Concentration-Time Curve Extrapolated From Last Measurable Concentration to Infinite Time (%AUC,ext)
Percentage of area under the plasma concentration-time curve extrapolated from last measurable concentration to infinite time (%AUC,ext) is calculated as (AUC [0-infinity] minus AUC [0-last])/ AUC [0-infinity])*100.
Measured: Predose, Up to Day 57
Apparent Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F will be calculated as CL/F = Dose/AUC [0-infinity]
Measured: Predose, Up to Day 57
Apparent Terminal Elimination Half-life (t1/2term)
Apparent terminal elimination half-life, calculated as 0.693/apparent terminal elimination rate constant (λz)
Measured: Predose, Up to Day 57
Apparent Terminal Elimination Rate Constant (lambda z)
Apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs time data
Measured: Predose, Up to Day 57
Apparent Volume of Distribution (Vd/F)
Apparent volume of distribution based on the terminal phase following oral administration calculated as Vd/F = Dose/ apparent terminal elimination rate constant (λz)*AUC [0-infinity]
Measured: Predose, Up to Day 57
Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)
Metabolite to parent drug ratio for Cmax will be assessed.
Measured: Predose, Up to Day 57
Metabolite to Parent Drug Ratio for Area Under Concentration from time zero to the last quantifiable concentration (MPR AUC [0-last])
Metabolite to parent drug ratio for AUC [0-last] will be assessed.
Measured: Predose, Up to Day 57
Metabolite to Parent Drug Ratio for Area Under Curve from time zero extrapolated to infinity (MPR AUC [0-infinity])
Metabolite to parent drug ratio for AUC [0-infinity] will be assessed.
Measured: Predose, Up to Day 57
Area Under Curve from time of administration to 24 hours post dosing
AUC from time of administration to 24 hours post dosing will be assessed.
Measured: Predose, Up to Day 57
Area Under Curve from time of administration to 168 hours post dosing
AUC from time of administration to 168 hours post dosing will be assessed.
Measured: Predose, Up to Day 57

Secondary outcomes (1)

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: Up to Day 57

Timeline

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

Jun 2016Dec 2016

First posted18 Jul 2016 (estimated)
Study startJun 2016
Primary completionDec 2016
Study completionDec 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.
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: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02835508
Sponsor's protocol ID: CR108165
Other IDs: 56021927PCR1021
Status last verified: Jan 2017
First submitted: 29 Jun 2016
Last updated: 11 Jan 2017
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?

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 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Pharmacokinetic Profile of JNJ-56021927 When Administered as the Tablet Formulation in Healthy Male Japanese Subjects
ClinicalTrials.gov ID: NCT02835508
Acronym / sponsor ID: CR108165
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 18 Jul 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment A	Experimental	Drug: JNJ-56021927 60 MilligramParticipants will receive a single dose of 1 tablet of JNJ-56021927, 60 milligram (mg) on Day 1.
Treatment B	Experimental	Drug: JNJ-56021927 120 MilligramParticipants will receive a single dose of JNJ-56021927, 120 mg (2 tablets*60 mg) on Day 1.
Treatment C	Experimental	Drug: JNJ-56021927 240 MilligramParticipants will receive a single dose of JNJ-56021927, 240 mg (4 tablets*60 mg) on Day 1.

Who may qualify

Ages: 20 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participant must have a body mass index between 18.0 and 29.9 Kilogram per meter square (kg/m^2), inclusive, and a body weight not less than 50 Kilogram (kg)
Participant must have a blood pressure between 90 and 140 Millimeters of Mercury (mm Hg) systolic, inclusive, and no higher than 90 mm Hg diastolic at screening
Participant must have a normal 12-lead Electrocardiogram (ECG) (based on the mean value of the triplicate parameters) consistent with normal cardiac conduction and function at screening, including: a) normal sinus rhythm (heart rate between 45 and 90 beats per minute, extremes included); b) QT interval corrected for heart rate according to Fridericia (QTcF) <= 450 milliseconds (ms); c) QRS interval less than or equal (<=)110 ms; d) PR interval <200 ms; e) ECG morphology consistent with healthy cardiac conduction and function
Participant must be a healthy Japanese male
Participant must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during intercourse and to not donate sperm during the study and for 3 months after study drug administration

Key exclusion criteria (5 listed)

Participant with 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
Participant has donated blood or blood product or had substantial loss of blood more than 200 milliliter (mL) within 1 month before study drug administration, or greater than equal (>=) 400 mL within 3 months before study drug administration, or participant has donated a total volume of blood in the past one year exceeding 1200 mL, or participant has an intention to donate blood or blood products during the study and for at least 2 months after completion of the study
Participant has presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc) or any medical condition that would affect sexual function
Participant has received an investigational drug including investigational vaccines or used an invasive investigational medical device within 3 months or within a period less than 10 times the drug's half-life, whichever is longer, before the planned study drug administration
Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-hepatitis C virus {HCV}) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at 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-56021927 60 MilligramAlso: apalutamideJNJ-56021927 60 mg oral tablet.	Drug	Treatment A
JNJ-56021927 120 MilligramAlso: apalutamideJNJ-56021927 120 mg as 2 tablets of 60 mg.	Drug	Treatment B
JNJ-56021927 240 MilligramAlso: apalutamideJNJ-56021927 240 mg as 4 tablets of 60 mg.	Drug	Treatment C

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: Predose, Up to Day 57
Maximum observed plasma concentration (Cmax) will be assessed.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Predose, Up to Day 57
Actual sampling time to reach maximum observed analyte concentration (Tmax) will be assessed.
Area Under Concentration from time zero to the last quantifiable AUC (0-last)
Time frame: Predose, Up to Day 57
AUC from time zero to the last quantifiable concentration will be assessed.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: Predose, Up to Day 57
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 (0-last) and C (0-last)/lambda(z); wherein AUC (0-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. AUC (0-infinity) will be assessed.
Time to Last Quantifiable Plasma Concentration (Tlast)
Time frame: Predose, Up to Day 57
The Tlast, time to last observed quantifiable plasma concentration will be assessed.
Percentage of Area Under the Plasma Concentration-Time Curve Extrapolated From Last Measurable Concentration to Infinite Time (%AUC,ext)
Time frame: Predose, Up to Day 57
Percentage of area under the plasma concentration-time curve extrapolated from last measurable concentration to infinite time (%AUC,ext) is calculated as (AUC [0-infinity] minus AUC [0-last])/ AUC [0-infinity])*100.
Apparent Clearance (CL/F)
Time frame: Predose, Up to Day 57
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F will be calculated as CL/F = Dose/AUC [0-infinity]
Apparent Terminal Elimination Half-life (t1/2term)
Time frame: Predose, Up to Day 57
Apparent terminal elimination half-life, calculated as 0.693/apparent terminal elimination rate constant (λz)
Apparent Terminal Elimination Rate Constant (lambda z)
Time frame: Predose, Up to Day 57
Apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs time data
Apparent Volume of Distribution (Vd/F)
Time frame: Predose, Up to Day 57
Apparent volume of distribution based on the terminal phase following oral administration calculated as Vd/F = Dose/ apparent terminal elimination rate constant (λz)*AUC [0-infinity]
Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)
Time frame: Predose, Up to Day 57
Metabolite to parent drug ratio for Cmax will be assessed.
Metabolite to Parent Drug Ratio for Area Under Concentration from time zero to the last quantifiable concentration (MPR AUC [0-last])
Time frame: Predose, Up to Day 57
Metabolite to parent drug ratio for AUC [0-last] will be assessed.
Metabolite to Parent Drug Ratio for Area Under Curve from time zero extrapolated to infinity (MPR AUC [0-infinity])
Time frame: Predose, Up to Day 57
Metabolite to parent drug ratio for AUC [0-infinity] will be assessed.
Area Under Curve from time of administration to 24 hours post dosing
Time frame: Predose, Up to Day 57
AUC from time of administration to 24 hours post dosing will be assessed.
Area Under Curve from time of administration to 168 hours post dosing
Time frame: Predose, Up to Day 57
AUC from time of administration to 168 hours post dosing will be assessed.

1 secondary outcome

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to Day 57

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 11 Jan 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 Pharmaceutical K.K. Clinical Trial study director

Janssen Pharmaceutical K.K.

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-56021927 60 Milligram, JNJ-56021927 120 Milligram and JNJ-56021927 240 Milligram in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.

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 11 Jan 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 Japan. 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 Observed Plasma Concentration (Cmax) (time frame: Predose, Up to Day 57). The study lists 15 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 NCT02835508.

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 11 Jan 2017.