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HealthyPhase 1NCT02160756

Bioavailability Study of 3 Tablet Formulations vs. Capsule Formulation of JNJ-56021927 in Fasting Healthy Male Participants

A Phase 1 study testing JNJ-56021927 Softgel Capsule, JNJ-56021927 Tablet Formulation 1 and JNJ-56021927 Tablet Formulation 2 in people with Healthy, run by Aragon Pharmaceuticals, Inc..

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 (PK - the study of the way a drug enters and leaves the blood and tissues over time) and relative bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-56021927, when administered as 3 tablet formulations… 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 Softgel Capsule, JNJ-56021927 Tablet Formulation 1 and JNJ-56021927 Tablet Formulation 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
No sites listed yet
Study dates
Jun 2014to Nov 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

  • Must agree to use an adequate contraception method as deemed appropriate by the investigator, always use a condom during sexual intercourse, and to not donate sperm during the study and for 3 months after receiving the study drug
  • Body mass index between 18 and 30 kilogram (kg) per square meter, and body weight not less than 50 kg
  • Blood pressure (supine for 5 minutes) between 90 and 140 millimeter of mercury (mm Hg) systolic, and no higher than 90 mm Hg diastolic
  • A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including pulse rate between 45 and 99 beats per minute (bpm), QT corrected Fridericia (QTcF) interval less than or equal to 450 milliseconds (msec), QRS interval of less than 120 msec, PR interval less than 220 msec, morphology consistent with healthy cardiac conduction and function
  • Nonsmoker within the previous 2 months

Who cannot join

  • History of or 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
  • Known hypersensitivity to Vitamin E
  • History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs
  • Known allergy to the study drug or any of the excipients of the formulation
  • Unable to swallow solid, oral dosage forms whole with the aid of water

About this study

Official title: A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Relative Bioavailability of 3 Tablet Formulations of JNJ-56021927 With Respect to the Capsule Formulation of JNJ-56021927 Under Fasted Conditions in Healthy Male Subjects

The purpose of this study is to evaluate the pharmacokinetics (PK - the study of the way a drug enters and leaves the blood and tissues over time) and relative bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-56021927, when administered as 3 tablet formulations (test) compared with JNJ-54781532 softgel capsule formulation (reference) in healthy male participants under fasted conditions at a single dose of 240 milligram (mg).

Read the detailed description

This is a randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), single-center, 4-treatment, parallel design (a medical research study comparing the response in two or more groups of participants receiving different interventions) study of a single dose of 240 mg JNJ-56021927. The duration of study will be approximately of 78 days per participant. The study consists of 3 parts: Screening phase (that is, 21 days before study commences on Day 1); Open-label Treatment phase (consists of 4 parallel single-dose treatments); and End-of-Study (completion of the Hour 1344 PK sampling on Day 57, or upon early withdrawal). All the eligible participants will be randomly assigned to 1 of the 4 possible treatments: Treatment A (240 mg dose as softgel capsule); Treatment B (240 mg dose as Tablet Formulation 1); Treatment C (240 mg dose as Tablet Formulation 2); or Treatment D (240 mg dose as Tablet Formulation 3). Participants will fast overnight from food and fluids (excluding non-carbonated water) for at least 10 hours before study drug administration on Day 1. Blood samples will be collected pre-dose and over 1,344 hours (Day 57) after dosing for the determination of JNJ-56021927 concentration and its active metabolite. Relative bioavailability of 3 tablet formulations as compared to the softgel capsule formulation of JNJ-56021927 will be evaluated primarily. Participants' safety will be monitored throughout the study.

Conditions
Healthy
Being tested
JNJ-56021927 Softgel Capsule, JNJ-56021927 Tablet Formulation 1, JNJ-56021927 Tablet Formulation 2, JNJ-56021927 Tablet Formulation 3
Keywords
Healthy, JNJ-56021927, JNJ-56142060, ARN-509

What participants receive

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

  • JNJ-56021927 Softgel CapsuleDrug

    Also called ARN-509

    Single oral dose of JNJ-56021927 240 mg softgel capsule on Day 1.

  • JNJ-56021927 Tablet Formulation 1Drug

    Single oral dose of JNJ-56021927 240 mg Tablet Formulation 1 on Day 1.

  • JNJ-56021927 Tablet Formulation 2Drug

    Single oral dose of JNJ-56021927 240 mg Tablet Formulation 2 on Day 1.

  • JNJ-56021927 Tablet Formulation 3Drug

    Single oral dose of JNJ-56021927 240 mg Tablet Formulation 3 on Day 1.

Study groups in NCT02160756
Study groupRoleWhat they receive
Treatment AActive comparatorSingle oral dose of JNJ-56021927 240 milligram (mg) softgel capsule on Day 1.
Receives: Drug: JNJ-56021927 Softgel Capsule
Treatment BExperimentalSingle oral dose of JNJ-56021927 240 mg Tablet Formulation 1 on Day 1.
Receives: Drug: JNJ-56021927 Tablet Formulation 1
Treatment CExperimentalSingle oral dose of JNJ-56021927 240 mg Tablet Formulation 2 on Day 1.
Receives: Drug: JNJ-56021927 Tablet Formulation 2
Treatment DExperimentalSingle oral dose of JNJ-56021927 240 mg Tablet Formulation 3 on Day 1.
Receives: Drug: JNJ-56021927 Tablet Formulation 3

What is being measured

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

  1. Maximum Plasma Concentration (Cmax)

    The Cmax is the maximum observed plasma concentration.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1

  2. Time to Reach Maximum Concentration (Tmax)

    The Tmax is time to reach the maximum observed plasma concentration.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1

  3. Area Under the Plasma Concentration-Time Curve From Time Zero to Time 72 Hours (AUC [0-72])

    Area Under the Plasma Concentration-Time Curve From Time Zero to Time 72 Hours (AUC [0-72]) will be evaluated.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72 hours post-administration of drug on Day 1

  4. Area Under the Plasma Concentration-Time Curve From Time Zero to Time 168 Hours (AUC [0-168])

    Area Under the Plasma Concentration-Time Curve From Time Zero to Time 168 Hours (AUC [0-168]) will be evaluated.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168 hours post-administration of drug on Day 1

  5. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])

    Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-last]) will be evaluated.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1

  6. Area Under the Curve From Time Zero to Extrapolated 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 Clast/lambda(z), wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time; Clast 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 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1

  7. Extrapolated Area Under the Curve (AUC Percent [%] Extrap)

    The AUC%extrap is the percentage of AUC [0-infinity] obtained by forward extrapolation. It is calculated as (AUC [0-infinity] minus AUC [0-last])*100/ AUC [0-infinity], where AUC [0-infinity] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1

  8. Elimination Half-Life (t1/2)

    Elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. Elimination half-life associated with the terminal slope of the semi-logarithmic drug concentration-time curve, calculated as 0.693/elimination rate constant (lambda[z]).

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1

  9. Elimination Rate Constant (lambda[z])

    Elimination rate constant is the fraction of a drug that is removed from the body per unit time.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1

  10. Time to Last Quantifiable Plasma Concentration (Tlast)

    The Tlast is time to reach the last quantifiable plasma concentration.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1

  11. Relative Bioavailability

    Bioavailability means the extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action. Relative bioavailability is the percentage of the administered dose that is systemically available, calculated as: (AUC [0-infinity] of test divided by AUC [0-infinity] of reference) multiplied by 100, where the reference treatment is a non-intravenous administration.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1

  12. Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)

    The (MPR Cmax) is metabolite to parent drug ratio for maximum observed plasma concentration.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1

  13. Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Quantifiable Concentration (MPR AUC[0-last])

    The MPR AUClast is metabolite to parent drug ratio for area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC [0-last]).

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1

  14. Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (MPR AUC [0-infinity])

    The MPR AUC [0-infinity] is metabolite to parent drug ratio for area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUC [0-infinity]).

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1

Secondary outcomes (1)

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are events between first dose of study drug and up to day 57, that are absent before treatment or that worsened relative to pretreatment state.

    Measured: Screening up to Day 57 or early withdrawal

Timeline

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

  1. First posted11 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

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
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02160756
Sponsor's protocol ID
CR104824
Other IDs
56021927PCR1011
Status last verified
Jan 2025
First submitted
9 Jun 2014
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-56021927 Softgel Capsule, JNJ-56021927 Tablet Formulation 1 and JNJ-56021927 Tablet Formulation 2 in people with Healthy, run by Aragon Pharmaceuticals, Inc..

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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

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) (time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1). 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 NCT02160756.

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.

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