A Study of (14C) Radiolabeled JNJ-56136379 in Healthy Male Participants

Janssen Research & Development, LLC6 enrolled

Overview

The purpose of this study is to investigate the absorption, the metabolic pathways, the route and rate of elimination, and total recovery of 14C-JNJ-56136379 and/or total drug derived radioactivity in healthy male adult participants after administration of a single oral dose of 14C-JNJ-56136379.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

14C-JNJ-56136379DRUG

14C-JNJ-56136379 25 mg dose formulated as a polyethylene glycol (PEG)-based oral solution containing 3,145 kilo Becquerel (kBq) of 14C labeled JNJ-56136379, with a maximal total radiation burden of 1,000 micro Sievert.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * During the study (from the day of study drug intake onwards) and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving study drug, a male participant: must agree: (a) to wear a condom when engaging in any activity that allows for passage of ejaculate to another person (male participant should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak); (b) not to donate sperm for the purpose of reproduction. Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies * Must have a body mass index (BMI; weight \[kg\]/height\^2 \[m\]\^2) between 18.0 and 30.0 kilogram per meter square (kg/m\^2) (inclusive), and body weight not less than 50 kilogram (kg) at screening * Healthy on the basis of physical examination, medical history and surgical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator * Healthy on the basis of clinical laboratory tests performed at screening * Must have a normal 12-lead electrocardiogram (ECG) at screening Exclusion Criteria: * Any evidence of heart block or bundle branch block at screening * Human immunodeficiency virus 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening * History of hepatitis A, B, C, or E infection, or current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E \[HEV\] antibody IgM \[in case HEV IgM positive, a confirmatory HEV ribonuclic acid {RNA} test should be performed\]) at screening * Any current, or history of, confirmed clinically significant skin disease requiring intermittent or chronic treatment such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria * A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs

Locations (1)

Covance Clinical Research Unit

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Cmax: Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma

Ratio of JNJ-56136379 concentration (plasma) and total radioactivity (plasma) for maximum observed plasma concentration (Cmax) will be assessed.

Time frame: Up to 552 hours postdose

AUC(0-last): Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma

Ratio of JNJ-56136379 concentration (plasma) and total radioactivity (plasma) for area under the plasma concentration-time curve from time zero to last quantifiable concentration time (AUC\[0-last\]) will be assessed.

Time frame: Up to 552 hours postdose

AUC(0-infinity): Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma

Ratio of JNJ-56136379 concentration (plasma) and total radioactivity (plasma) for area under the plasma concentration- time curve from time zero to infinite time (AUC \[0-infinity\]) will be assessed.

Time frame: Up to 552 hours postdose

Total Radioactivity in Whole Blood, Plasma, Feces and Urine for 14C-JNJ-56136379

The total radioactivity of 14C-JNJ-56136379 in the whole blood plasma, feces and urine will be calculated.

Time frame: Up to 552 hours postdose

Total Recovery of Radioactive Dose in Feces and Urine for 14C-JNJ-56136379

The amount of 14C-JNJ-56136379 recovered from the total administered radioactive dose in the feces and urine will be calculated.

Time frame: Up to 552 hours postdose

Secondary Outcomes

Metabolic Profiles of JNJ-56136379 in Plasma, Urine, and Feces

The metabolite profiling of JNJ-56136379 in different matrices like plasma, urine, and feces will be performed and reported.

Data from ClinicalTrials.gov

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Time frame: Predose (Day 1), 1, 2, 4, 8, 24, 48, 96, 192, 288, 432, 552 hours postdose (Day 24)

Maximum Observed Plasma Concentration (Cmax) of JNJ-56136379

Cmax is defined as the maximum observed plasma concentration.

Time frame: Predose (Day 1), 1, 2, 4, 8, 24, 48, 96, 192, 288, 432, 552 hours postdose (Day 24)

Actual Sampling Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379

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

Time frame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)

Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0- Last]) of JNJ-56136379

AUC(0-Last) is area under the plasma concentration-time curve from time zero to time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.

Time frame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)

Area Under the Plasma Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-56136379

AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-below quantification limit) concentration.

Time frame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)

Percentage of AUC(0-inifinity) (%AUC[0- infinity],ex of JNJ-56136379

%AUC(0-infinity).ex is the percentage of AUC obtained by extrapolation, calculated by the following equation: (AUC\[0-inifinity\] - AUC\[0-last\])/AUC(0-inifinity)\*100.

Time frame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)

Apparent Terminal Elimination Half-Life (t1/2) of JNJ-56136379

The t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve, and is calculated as 0.693/lambda(z).

Time frame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)

Apparent Terminal Elimination Rate Constant (Lambda[z]) of JNJ-56136379

Lambda(z) is first-order elimination 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: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)

Amount of JNJ-56136379 Excreted in Urine within the Time Interval t1 to t2 (Ae[t1-t2])

Ae(t1-t2) is the amount of JNJ-56136379 excreted into urine for the collection interval from t1 to t2, where t1 and t2 are the start and end times of the interval, respectively, calculated by multiplying the urinary volume with the urinary concentration for that interval.