Clinical trial NCT03864601: A Study of (14C) Radiolabeled JNJ-56136379 in Healthy Male Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-03-06
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cmax: Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma
timeFrame: Up to 552 hours postdose
measure: AUC(0-last): Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma
timeFrame: Up to 552 hours postdose
measure: AUC(0-infinity): Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma
timeFrame: Up to 552 hours postdose
measure: Total Radioactivity in Whole Blood, Plasma, Feces and Urine for 14C-JNJ-56136379
timeFrame: Up to 552 hours postdose
measure: Total Recovery of Radioactive Dose in Feces and Urine for 14C-JNJ-56136379
timeFrame: Up to 552 hours postdose
Secondary outcomes:
measure: Metabolic Profiles of JNJ-56136379 in Plasma, Urine, and Feces
timeFrame: Predose (Day 1), 1, 2, 4, 8, 24, 48, 96, 192, 288, 432, 552 hours postdose (Day 24)
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-56136379
timeFrame: Predose (Day 1), 1, 2, 4, 8, 24, 48, 96, 192, 288, 432, 552 hours postdose (Day 24)
measure: Actual Sampling Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379
timeFrame: 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)
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0- Last]) of JNJ-56136379
timeFrame: 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)
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-56136379
timeFrame: 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)
measure: Percentage of AUC(0-inifinity) (%AUC[0- infinity],ex of JNJ-56136379
timeFrame: 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)
measure: Apparent Terminal Elimination Half-Life (t1/2) of JNJ-56136379
timeFrame: 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)
measure: Apparent Terminal Elimination Rate Constant (Lambda[z]) of JNJ-56136379
timeFrame: 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)
measure: Amount of JNJ-56136379 Excreted in Urine within the Time Interval t1 to t2 (Ae[t1-t2])
timeFrame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
measure: Amount of JNJ-56136379 Excreted in Urine (Ae)
timeFrame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
measure: Percentage of JNJ-56136379 Excreted in Urine (Ae%dose)
timeFrame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
measure: Amount of JNJ-56136379 Excreted in Feces within the Time Interval t1 to t2 (Fe[t1-t2])
timeFrame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
measure: Amount of JNJ-56136379 Excreted in Feces (Fe)
timeFrame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
measure: Percentage of JNJ-56136379 Excreted in Feces (Fe,%dose)
timeFrame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Approximately up to 2.5 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: