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

NCT ID: NCT03002779

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-26
• Study Completion Date: 2017-03-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JNJ-53718678

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: 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.

Interventions

JNJ-53718678

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

53718678RSV1008

Identifier Type: OTHER

Identifier Source: secondary_id

2016-002664-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108210

Identifier Type: -

Identifier Source: org_study_id