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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 14C-JNJ-56136379

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 14C-JNJ-56136379; Participants will receive a single oral 25 milligram (mg) dose of 14C-JNJ-56136379 on Day 1 under fed conditions.	Drug: 14C-JNJ-56136379; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Up to 552 hours postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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).	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.	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.	Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Amount of JNJ-56136379 Excreted in Urine (Ae)	The Ae is the amount of JNJ-56136379 excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.	Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Percentage of JNJ-56136379 Excreted in Urine (Ae%dose)	The Ae%dose is the percentage of JNJ-56136379 dose excreted into the urine calculated as (Ae/dose)∗100.	Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Amount of JNJ-56136379 Excreted in Feces within the Time Interval t1 to t2 (Fe[t1-t2])	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.	Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Amount of JNJ-56136379 Excreted in Feces (Fe)	The Fe is the amount of JNJ-56136379 excreted in feces. It is calculated by multiplying the fecal volume with the fecal drug concentration.	Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Percentage of JNJ-56136379 Excreted in Feces (Fe,%dose)	The Fe%dose is the percentage of JNJ-56136379 dose excreted into the feces calculated as (Fe/dose)*100.	Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	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.	Approximately up to 2.5 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Actual): June 14, 2019
• Study Completion (Actual): June 14, 2019

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; JNJ-56136379
• Other Study ID Numbers: CR108586; 56136379HPB1007 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No