CClinicalTrials.gg
Sign In
CompletedNCT02031666Updated Oct 20, 2016

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 interventional study of JNJ-56021927 capsule and JNJ-56021927 tablet in Healthy, sponsored by Aragon Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-20.

Sponsored by Aragon Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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 capsule formulation of JNJ-56021927 in healthy male participants under fasted conditions at a single dose of 240 mg.

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.

02

Conditions studied

  • Healthy

Keywords

  • Healthy
  • JNJ-56021927
  • ARN-509
  • Bioavailability
03

In context

Lead sponsor

Aragon Pharmaceuticals, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Treatment A

    15 participants will receive 240-mg dose as Softgel Capsule Formulation of JNJ-56021927.

    Drug: JNJ-56021927 capsule

  • Experimental
    Treatment B

    15 participants will receive 240-mg dose as Tablet Formulation number 1 of JNJ-56021927.

    Drug: JNJ-56021927 tablet

  • Experimental
    Treatment C

    15 participants will receive 240-mg dose as Tablet Formulation number 2 of JNJ-56021927.

    Drug: JNJ-56021927 tablet

  • Experimental
    Treatment D

    15 participants will receive 240-mg dose as Tablet Formulation number 3 of JNJ-56021927.

    Drug: JNJ-56021927 tablet

  • Experimental
    Treatment E

    15 participants will receive 240-mg dose as Tablet Formulation number 4 of JNJ-56021927.

    Drug: JNJ-56021927 tablet

  • Experimental
    Treatment F

    15 participants will receive 240-mg dose as Tablet Formulation number 5 of JNJ-56021927.

    Drug: JNJ-56021927 tablet

  • Experimental
    Treatment G

    15 participants will receive 240-mg dose as Tablet Formulation number 6 of JNJ-56021927.

    Drug: JNJ-56021927 tablet

  • Experimental
    Treatment H

    15 participants will receive 240-mg dose as Tablet Formulation number 7 of JNJ-56021927.

    Drug: JNJ-56021927 tablet

Interventions

  • DrugJNJ-56021927 capsule

    Participants will receive oral soft gel capsules providing a total dose of 240 mg JNJ-56021927 on Day 1.

    Also known as: ARN-509

  • DrugJNJ-56021927 tablet

    Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of JNJ-56021927

    The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.

    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

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-56021927

    Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

    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

  3. 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.

    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

  4. 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.

    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

  5. 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.

    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

  6. 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.

    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

  7. 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).

    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

  8. 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.

    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

  9. 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

  10. Relative Bioavailability (Frel) of JNJ-56021927

    Relative bioavailability is the percentage of the administered dose that is systemically available.

    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

  11. Metabolite to Parent Drug Ratio for Cmax of JNJ-56021927

    Metabolite to parent drug ratio for maximum observed plasma concentration.

    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

  12. 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).

    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

  13. 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.

    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

  14. Number of Participants With Adverse Events as a Measure of Safety and Tolerabilty

    Time frame: Up to Day 57

07

Study locations

1 site
  • Tempe, Arizona, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02031666
Lead sponsor
Aragon Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jan 9, 2014
Start date
Dec 2013
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Oct 20, 2016

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Aragon Pharmaceuticals, Inc.

Start the discussion