Study to Assess the Absorption, Metabolism and Excretion of 14C-JNJ-63623872 After a Single Dose in Healthy Male Participants

NCT ID: NCT02448004

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-11
• Study Completion Date: 2015-06-24

Brief Summary

The primary objective of this study is to characterize the absorption and metabolic pathways of JNJ-63623872, and the excretion of the compound and its metabolites, after single oral dosing of 14C-JNJ-63623872 in healthy adult male participants.

Detailed Description

This is a Phase 1, open-label (all people know the identity of the intervention), single dose study in 6 healthy adult male participants to characterize the absorption, metabolism and excretion of 14C-JNJ-63623872. The total study duration will be approximately of 16 days per participant. The study consists of 3 parts: Screening (that is, 28 days before study commences on Day 1); open-Label Treatment Phase(that is, Day 1); and Follow-up (that is, up to Day 16). All the eligible participants will receive 14C-JNJ-63623872 at a dose level of 600 milligram. Participants will enter the study site on Day -1 and stay at the study site at least until Day 8. Urine, feces, whole blood samples, plasma, nasal mucus and saliva samples will be collected up to Day 8. Unchanged JNJ-63623872 will be determined in plasma and, if feasible, in saliva. Participants' safety will be monitored throughout the study.

Conditions

Healthy

Study Design

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

Study Groups

JNJ-63623872

Participants will receive a single 600-milligram (mg) dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872.

Group Type: EXPERIMENTAL

JNJ-63623872

Intervention Type: DRUG

Participants will receive a single 600-mg dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872.

Interventions

JNJ-63623872

Participants will receive a single 600-mg dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872.

Intervention Type: DRUG

Other Intervention Names

14C-JNJ-63623872

Eligibility Criteria

Inclusion Criteria

• Participants must agree to comply with contraceptive measures as mentioned in protocol
• Must be non-smokers for at least 3 months prior to screening
• Must have a Body Mass Index (BMI; weight in kilogram divided by the square of height in meters) of 18.0 to 30.0 kilogram/meter square, extremes included
• Must have signed an Informed consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study before starting any screening activities
• Must be willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
• Must have a normal 12-lead ECG (based on the mean value of the triplicate parameters) at screening and on Day 1 predose including: 1). normal sinus rhythm (heart rate between 45 and 100 beats per minute [bpm], extremes included); 2). QT interval corrected for heart rate according to Fridericia (QTcF) interval less than or equal to (<=) 450 milliseconds (ms); 3). QRS interval lower than 120 ms; 4). PR interval <= 220 ms

Exclusion Criteria

• Participants with a past history of heart arrhythmias (extrasystoli clinically significant in the opinion of the investigator, tachycardia at rest) or of risk factors for Torsade de Pointes syndrome
• Participants with more than one episode of constipation (less than 1 stool per 3 days) during the last 2 months, or more than one episode of diarrhea (3 or more stools per day) during the last 2 months
• Participants with a history of or a reason to believe the subject has a history of drug or alcohol abuse within the past 5 years
• Participants having a positive urine drug test at study screening or on Day -1. Urine will be tested for the presence of amphetamines, benzodiazepines, cocaine, cannabinoids, opioids, methadone and barbiturates
• Participants with documented human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at study screening
• Participants with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M ([IgM]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen [HbsAg]), or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at study screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Cilag N.V./S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Cilag N.V./S.A., Belgium Clinical Trial

Role: STUDY_DIRECTOR

Janssen Cilag N.V./S.A.

Locations

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

63623872FLZ1007

Identifier Type: OTHER

Identifier Source: secondary_id

2015-000719-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR107301

Identifier Type: -

Identifier Source: org_study_id