A Study to Characterize the Absorption, Metabolism, and Excretion of 14C-JNJ-53718678 After a Single Oral Dose in Healthy Male Participants

NCT03002779 | Completed Phase 1

• 3 other identifiers: CR10821053718678RSV10082016-002664-14
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical structure of predominant metabolites in healthy adult male participants after a single oral dose of 500 milligram (mg) 14C-JNJ-53718678.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Mass Balance of JNJ-53718678 in Healthy Adult Male Participants.

  Total mass balance calculated by D(dose) urine, total (percent \[%\]) + D feces, total (%) + D duodenal, total (%) where D urine, total is the total percentage of the dose excreted into urine, calculated as 100 \* (Ae total \[total amount excreted into urine, calculated by adding the amounts of the individual intervals together\] /Dose); D feces,total is the total percentage of the dose excreted into feces, calculated as 100 \* (Ae total \[total amount excreted into feces, calculated by adding the amounts of the individual stools together\]/Dose) and D duodenal, total is defined as total percentage of the dose collected in all duodenal samples collectively, calculated as % of dose.

  Up to Day 10

• Metabolic profiles of JNJ-53718678 in plasma, duodenal fluid, urine, and feces samples with radio high-performance liquid chromatography analysis

  Metabolite profiling will be performed with radio high-performance liquid chromatography.

  Up to Day 6

Secondary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Throughout the study duration (up to 24 days)

Study Arms (1)

JNJ-53718678

EXPERIMENTAL

Drug: JNJ-53718678

Interventions

JNJ-53718678 DRUG

Participants will receive a single 500 milligram (mg) dose of 14C-JNJ-53718678 as an oral liquid solution containing 14C-labeled and unlabeled JNJ-53718678 corresponding to a radioactivity dose.

JNJ-53718678

Eligibility Criteria

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

You may qualify if:

• A male participant: a) Must be sexually abstinent (defined as refraining from sexual intercourse from Day 1 (day of dosing) until 90 days after study drug administration), OR b) Who is sexually active (either heterosexual, including with a pregnant woman, or homosexual) must agree to use a barrier method of contraception (eg, condom) from Day 1 (day of dosing) until 90 days after study drug administration, AND c) Who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (eg, condom) from Day 1 (day of dosing) until 90 days after study drug administration, in conjunction with this female partner using a highly effective contraceptive (such as implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system, combined \[estrogen- and progestogen- containing\] hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal; progestogen-only hormone contraception associated with inhibition of ovulation: oral or injectable) d) Must agree not to donate sperm from Day 1 (day of dosing) until 90 days after study drug administration
• Participant must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m\^2)
• Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
• Participant must have a normal 12-lead electrocardiogram (ECG) (based on the mean value of triplicate ECG parameters), consistent with normal cardiac conduction and function at screening, including: a) normal sinus rhythm (heart rate between 45 and 90 beats per minute (bpm), extremes included); b)mean QT interval corrected for heart rate according to Fridericia formula (QTcF) interval lesser than or equal to (\<=)450 millisecond (ms); c) mean QRS interval of \<110 ms; d) mean PR interval \<200 ms; e) morphology consistent with healthy cardiac conduction and function

You may not qualify if:

• Participants with a removed gallbladder, or with a history of upper gastrointestinal (stomach, duodenum) surgery, or with a recent (less than 3 months prior to screening) episode of gallbladder stones
• Participants with a history of heart arrhythmias (extrasystoles, tachycardia at rest) or history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT syndrome)
• Participant has intolerance to xylocaine, lactose, or midazolam
• Participant has a history of hepatitis A antibody immunoglobulin M (IgM), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for hepatitis A antibody IgM, HBsAg or anti HCV at screening
• Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Interventions

JNJ-53718678

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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 26, 2016
• Study Start: January 26, 2017
• Primary Completion: March 10, 2017
• Study Completion: March 20, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

NL (1)