A Phase 1 interventional study of JNJ-56021927 Softgel Capsule and JNJ-56021927 Tablet Formulation 1 in Healthy, sponsored by Aragon Pharmaceuticals, Inc.. Completed. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Aragon Pharmaceuticals, Inc. (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
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).
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.
Aragon Pharmaceuticals, Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.
First submitted after Aragon Pharmaceuticals, Inc. became part of Johnson & Johnson.
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Exclusion Criteria:
Single oral dose of JNJ-56021927 240 milligram (mg) softgel capsule on Day 1.
Drug: JNJ-56021927 Softgel Capsule
Single oral dose of JNJ-56021927 240 mg Tablet Formulation 1 on Day 1.
Drug: JNJ-56021927 Tablet Formulation 1
Single oral dose of JNJ-56021927 240 mg Tablet Formulation 2 on Day 1.
Drug: JNJ-56021927 Tablet Formulation 2
Single oral dose of JNJ-56021927 240 mg Tablet Formulation 3 on Day 1.
Drug: JNJ-56021927 Tablet Formulation 3
Single oral dose of JNJ-56021927 240 mg softgel capsule on Day 1.
Also known as: ARN-509
Single oral dose of JNJ-56021927 240 mg Tablet Formulation 1 on Day 1.
Single oral dose of JNJ-56021927 240 mg Tablet Formulation 2 on Day 1.
Single oral dose of JNJ-56021927 240 mg Tablet Formulation 3 on Day 1.
Maximum Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration.
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
Time to Reach Maximum Concentration (Tmax)
The Tmax is time to reach the maximum observed plasma concentration.
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
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.
Time frame: 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
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.
Time frame: 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
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.
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
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.
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
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.
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
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\[z\]).
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
Elimination Rate Constant (lambda[z])
Elimination rate constant is the fraction of a drug that is removed from the body per unit time.
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
Time to Last Quantifiable Plasma Concentration (Tlast)
The Tlast is time to reach the last quantifiable plasma concentration.
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
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.
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
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.
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
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 \[0-last\]).
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
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 \[0-infinity\]).
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
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.
Time frame: Screening up to Day 57 or early withdrawal
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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