Clinical trial NCT02448004: Study to Assess the Absorption, Metabolism and Excretion of 14C-JNJ-63623872 After a Single Dose in Healthy Male Participants
Official title: A Phase 1, Open-label Study to Characterize the Absorption, Metabolism and Excretion of 14C-JNJ-63623872 After a Single Dose in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
JNJ-63623872
14C-JNJ-63623872
Lead sponsor: Janssen Cilag N.V./S.A.
Sponsor class: INDUSTRY
First posted: 2015-05-19
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of JNJ-63623872
timeFrame: Baseline up to Day 8
measure: Time to reach maximum concentration (tmax) of JNJ-63623872
timeFrame: Baseline up to Day 8
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Last (AUC [0-last]) of JNJ-63623872
timeFrame: Baseline up to Day 8
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-63623872
timeFrame: Baseline up to Day 8
measure: Terminal Half-Life(t[1/2]) of JNJ-63623872
timeFrame: Baseline up to Day 8
measure: Rate Constant (Lambda[z])
timeFrame: Baseline up to Day 8
measure: Apparent total body clearance (CL/F) of JNJ-63623872
timeFrame: Baseline up to Day 8
measure: Apparent volume of distribution at the terminal Phase (Vd[z] /F) of JNJ-63623872
timeFrame: Baseline up to Day 8
measure: Amount of JNJ-63623872 excreted in Urine (Ae[x-y])
timeFrame: Baseline up to Day 8
measure: Total Amount of JNJ-63623872 excreted in Urine (Ae[total])
timeFrame: Baseline up to Day 8
measure: Percentage of JNJ-63623872 dose excreted into urine
timeFrame: Baseline up to Day 8
measure: Total Percentage of JNJ-63623872 dose excreted into urine
timeFrame: Baseline up to Day 8
measure: Renal clearance
timeFrame: Baseline up to Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
Study officials:
affiliation: Janssen Cilag N.V./S.A.
name: Janssen Cilag N.V./S.A., Belgium Clinical Trial
role: STUDY_DIRECTOR
References: