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Completed

NCT Number: NCT03864601

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

14C-JNJ-56136379

Drug

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.

Primary outcomes

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

    Time frame: Up to 552 hours postdose

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

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

    Time frame: Up to 552 hours postdose

    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.

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

    Time frame: Up to 552 hours postdose

    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.

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

    Time frame: Up to 552 hours postdose

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

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

    Time frame: Up to 552 hours postdose

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

Secondary outcomes

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

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

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

  2. Maximum Observed Plasma Concentration (Cmax) of JNJ-56136379

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

    Cmax is defined as the maximum observed plasma concentration.

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

    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)

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

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

    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)

    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.

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

    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)

    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.

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

    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)

    %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.

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

    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)

    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).

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

    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)

    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.

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

    Time frame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose

    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.

  10. Amount of JNJ-56136379 Excreted in Urine (Ae)

    Time frame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose

    The Ae is the amount of JNJ-56136379 excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.

  11. Percentage of JNJ-56136379 Excreted in Urine (Ae%dose)

    Time frame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose

    The Ae%dose is the percentage of JNJ-56136379 dose excreted into the urine calculated as (Ae/dose)∗100.

  12. Amount of JNJ-56136379 Excreted in Feces within the Time Interval t1 to t2 (Fe[t1-t2])

    Time frame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose

    The Fe(t1-t2) is the amount of JNJ-56136379 excreted into feces 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 fecal volume with the fecal concentration for that interval.

  13. Amount of JNJ-56136379 Excreted in Feces (Fe)

    Time frame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose

    The Fe is the amount of JNJ-56136379 excreted in feces. It is calculated by multiplying the fecal volume with the fecal drug concentration.

  14. Percentage of JNJ-56136379 Excreted in Feces (Fe,%dose)

    Time frame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose

    The Fe%dose is the percentage of JNJ-56136379 dose excreted into the feces calculated as (Fe/dose)*100.

  15. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    Time frame: Approximately up to 2.5 months

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1, Open-label Study to Determine the Absorption, Metabolism, and Routes of Excretion, Following Oral Administration of (14C) Radiolabeled JNJ-56136379 in Healthy Male Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2019
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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