HealthyPhase 1NCT02031666

A Study to Assess the Relative Bioavailability of 7 Test Tablet Formulations of JNJ-56021927 With Respect to the Capsule Formulation of JNJ-56021927 in Healthy Male Participants

A Phase 1 study testing JNJ-56021927 capsule and JNJ-56021927 tablet in people with Healthy, run by Aragon Pharmaceuticals, Inc. at 1 site in United States.

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 pharmacokinetics (what the body does to the medication) and relative bioavailability (the extent to which a medication or other substance becomes available to the body) of JNJ-56021927 when administered as 7 test tablet formulations of JNJ-56021927 compared with the softgel… Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: JNJ-56021927 capsule and JNJ-56021927 tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: Dec 2013to Apr 2014
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

During the study and for 3 months after receiving study medication, must agree to use an adequate contraception method (eg, vasectomy, double-barrier, partner using effective contraception), always use a condom during sexual intercourse and to not donate sperm
Body mass index (weight [kg]/height [m]2) between 18 and 30 kg/m2 and body weight not less than 50 kg
Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
Non-smoker for 2 months prior to study participation

Who cannot join

History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease (including bronchospastic respiratory disease), diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, and infection
Clinically significant abnormal values for hematology, clinical chemistry or urinalysis, physical examination, vital signs or 12-lead ECG at screening or at admission to the study center as deemed appropriate by the investigator
Presence of sexual dysfunction (eg, abnormal libido or erectile dysfunction) or any medical condition that would affect sexual function
Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen within 14 days before the first dose of the study drug is scheduled
History of clinically significant allergies or known hypersensitivity to vitamin E

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Tempe, Arizona

Other trials in United States

About this study

Official title: A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Relative Bioavailability of 7 Test Tablet Formulations of JNJ-56021927 With Respect to the Capsule Formulation of JNJ-56021927 Under Fasted Conditions in Healthy Male Subjects

Read the detailed description

This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), single-center, 8-treatment, parallel-group (each group of participants will be treated at the same time) study. Approximately 120 participants (15 participants in each treatment group) will participate in this study. All participants will be randomly assigned to 1 of 8 possible treatments (A, B, C, D, E, F, G, and H). The study will consist of a screening phase (within 21 days before the first administration of the study medication), a treatment phase with 8 parallel single-dose treatments (8 days); a follow up phase (42 days) and an end-of-study or early withdrawal assessments (Day 57). Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, vital signs, and physical examination which will be monitored throughout the study. The duration of participation in the study for an individual participant will be approximately 78 days.

Conditions: Healthy
Being tested: JNJ-56021927 capsule, JNJ-56021927 tablet
Keywords: Healthy, JNJ-56021927, ARN-509, Bioavailability

What participants receive

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

JNJ-56021927 capsuleDrug
Also called ARN-509
Participants will receive oral soft gel capsules providing a total dose of 240 mg JNJ-56021927 on Day 1.
JNJ-56021927 tabletDrug
Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.

Study groups in NCT02031666
Study group	Role	What they receive
Treatment A	Active comparator	15 participants will receive 240-mg dose as Softgel Capsule Formulation of JNJ-56021927. Receives: Drug: JNJ-56021927 capsule
Treatment B	Experimental	15 participants will receive 240-mg dose as Tablet Formulation number 1 of JNJ-56021927. Receives: Drug: JNJ-56021927 tablet
Treatment C	Experimental	15 participants will receive 240-mg dose as Tablet Formulation number 2 of JNJ-56021927. Receives: Drug: JNJ-56021927 tablet
Treatment D	Experimental	15 participants will receive 240-mg dose as Tablet Formulation number 3 of JNJ-56021927. Receives: Drug: JNJ-56021927 tablet
Treatment E	Experimental	15 participants will receive 240-mg dose as Tablet Formulation number 4 of JNJ-56021927. Receives: Drug: JNJ-56021927 tablet
Treatment F	Experimental	15 participants will receive 240-mg dose as Tablet Formulation number 5 of JNJ-56021927. Receives: Drug: JNJ-56021927 tablet
Treatment G	Experimental	15 participants will receive 240-mg dose as Tablet Formulation number 6 of JNJ-56021927. Receives: Drug: JNJ-56021927 tablet
Treatment H	Experimental	15 participants will receive 240-mg dose as Tablet Formulation number 7 of JNJ-56021927. Receives: Drug: JNJ-56021927 tablet

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of JNJ-56021927
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Measured: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-56021927
Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Area Under the Plasma Concentration-Time Curve From Time of Administration to 72 hours After Dosing (AUC 0-72h) of JNJ-56021927
The AUC 0-72h is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Measured: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Area Under the Plasma Concentration-Time Curve From Time of Administration to 168 hours After Dosing (AUC 0-168h) of JNJ-56021927
The AUC 0-168h is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Measured: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUClast) of JNJ-56021927
The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Measured: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-56021927
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration and lambda[z] is the terminal rate-constant of the semi logarithmic drug concentration-time curve.
Measured: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Elimination Half-Life Period (T1/2) of JNJ-56021927
The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half of its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Measured: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
First-order Rate Constant of JNJ-56021927
The 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: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Time to Last Quantifiable Plasma Concentration (tlast) of JNJ-56021927
Measured: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Relative Bioavailability (Frel) of JNJ-56021927
Relative bioavailability is the percentage of the administered dose that is systemically available.
Measured: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Metabolite to Parent Drug Ratio for Cmax of JNJ-56021927
Metabolite to parent drug ratio for maximum observed plasma concentration.
Measured: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Metabolite to Parent Drug Ratio for AUClast of JNJ-56021927
Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to time of the last observed quantifiable concentration (Clast).
Measured: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Metabolite to Parent Drug Ratio for AUCinfinity of JNJ-56021927
Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to infinite time, calculated as the sum of AUClast and Clast/ first-order rate constant, in which Clast is the last observed quantifiable concentration.
Measured: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Number of Participants With Adverse Events as a Measure of Safety and Tolerabilty
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.

Dec 2013Apr 2014

First posted9 Jan 2014 (estimated)
Study startDec 2013
Primary completionApr 2014
Study completionApr 2014

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: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02031666
Sponsor's protocol ID: CR103299
Other IDs: 56021927PCR1007
Status last verified: Oct 2016
First submitted: 7 Jan 2014
Last updated: 20 Oct 2016
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 20 Oct 2016. 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 Relative Bioavailability of 7 Test Tablet Formulations of JNJ-56021927 With Respect to the Capsule Formulation of JNJ-56021927 Under Fasted Conditions in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02031666
Acronym / sponsor ID: CR103299
Conditions: Healthy
Keywords: Healthy, JNJ-56021927, ARN-509, Bioavailability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Aragon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 9 Jan 2014 (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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Treatment A	Active comparator	Drug: JNJ-56021927 capsule15 participants will receive 240-mg dose as Softgel Capsule Formulation of JNJ-56021927.
Treatment B	Experimental	Drug: JNJ-56021927 tablet15 participants will receive 240-mg dose as Tablet Formulation number 1 of JNJ-56021927.
Treatment C	Experimental	Drug: JNJ-56021927 tablet15 participants will receive 240-mg dose as Tablet Formulation number 2 of JNJ-56021927.
Treatment D	Experimental	Drug: JNJ-56021927 tablet15 participants will receive 240-mg dose as Tablet Formulation number 3 of JNJ-56021927.
Treatment E	Experimental	Drug: JNJ-56021927 tablet15 participants will receive 240-mg dose as Tablet Formulation number 4 of JNJ-56021927.
Treatment F	Experimental	Drug: JNJ-56021927 tablet15 participants will receive 240-mg dose as Tablet Formulation number 5 of JNJ-56021927.
Treatment G	Experimental	Drug: JNJ-56021927 tablet15 participants will receive 240-mg dose as Tablet Formulation number 6 of JNJ-56021927.
Treatment H	Experimental	Drug: JNJ-56021927 tablet15 participants will receive 240-mg dose as Tablet Formulation number 7 of JNJ-56021927.

Who may qualify

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

Key inclusion criteria (5 listed)

During the study and for 3 months after receiving study medication, must agree to use an adequate contraception method (eg, vasectomy, double-barrier, partner using effective contraception), always use a condom during sexual intercourse and to not donate sperm
Body mass index (weight [kg]/height [m]2) between 18 and 30 kg/m2 and body weight not less than 50 kg
Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
Non-smoker for 2 months prior to study participation

Key exclusion criteria (5 listed)

History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease (including bronchospastic respiratory disease), diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, and infection
Clinically significant abnormal values for hematology, clinical chemistry or urinalysis, physical examination, vital signs or 12-lead ECG at screening or at admission to the study center as deemed appropriate by the investigator
Presence of sexual dysfunction (eg, abnormal libido or erectile dysfunction) or any medical condition that would affect sexual function
Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen within 14 days before the first dose of the study drug is scheduled
History of clinically significant allergies or known hypersensitivity to vitamin E

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 capsuleAlso: ARN-509Participants will receive oral soft gel capsules providing a total dose of 240 mg JNJ-56021927 on Day 1.	Drug	Treatment A
JNJ-56021927 tabletParticipants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.	Drug	Treatment B, Treatment C, Treatment D, Treatment E, Treatment F, Treatment G, Treatment H

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Area Under the Plasma Concentration-Time Curve From Time of Administration to 72 hours After Dosing (AUC 0-72h) of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
The AUC 0-72h is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Area Under the Plasma Concentration-Time Curve From Time of Administration to 168 hours After Dosing (AUC 0-168h) of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
The AUC 0-168h is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUClast) of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration and lambda[z] is the terminal rate-constant of the semi logarithmic drug concentration-time curve.
Elimination Half-Life Period (T1/2) of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half of its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
First-order Rate Constant of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
The 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.
Time to Last Quantifiable Plasma Concentration (tlast) of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Relative Bioavailability (Frel) of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Relative bioavailability is the percentage of the administered dose that is systemically available.
Metabolite to Parent Drug Ratio for Cmax of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Metabolite to parent drug ratio for maximum observed plasma concentration.
Metabolite to Parent Drug Ratio for AUClast of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to time of the last observed quantifiable concentration (Clast).
Metabolite to Parent Drug Ratio for AUCinfinity of JNJ-56021927
Time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57
Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to infinite time, calculated as the sum of AUClast and Clast/ first-order rate constant, in which Clast is the last observed quantifiable concentration.
Number of Participants With Adverse Events as a Measure of Safety and Tolerabilty
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 20 Oct 2016.

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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-56021927 capsule and JNJ-56021927 tablet in people with Healthy, run by Aragon Pharmaceuticals, Inc. at 1 site in United States.

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 20 Oct 2016. 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 United States. 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) of JNJ-56021927 (time frame: Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57). The study lists 14 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 NCT02031666.

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 20 Oct 2016.