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

NCT03864601 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10858656136379HPB1007
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (15)

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

  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

  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

  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

  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

  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)

Study Arms (1)

14C-JNJ-56136379

EXPERIMENTAL

Participants will receive a single oral 25 milligram (mg) dose of 14C-JNJ-56136379 on Day 1 under fed conditions.

Drug: 14C-JNJ-56136379

Interventions

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.

14C-JNJ-56136379

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 6, 2019
• Study Start: April 9, 2019
• Primary Completion: June 14, 2019
• Study Completion: June 14, 2019
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)