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

• Status: Completed
• Trial end date: 2015-06-24
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Cilag N.V./S.A.

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