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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448004
• Other study ID #: CR107301
• Secondary ID: 63623872FLZ10072
• Status: Completed
• Phase: Phase 1
• First received: May 15, 2015
• Last updated: June 30, 2017
• Start date: May 11, 2015
• Est. completion date: June 24, 2015

Study information

• Verified date: June 2017
• Source: Janssen Cilag N.V./S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 24, 2015
• Est. primary completion date: June 24, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Cilag N.V./S.A.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax) of JNJ-63623872	The Cmax is the maximum plasma concentration.	Baseline up to Day 8
Primary	Time to reach maximum concentration (tmax) of JNJ-63623872	The Tmax is time to reach the maximum plasma concentration.	Baseline up to Day 8
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to Last (AUC [0-last]) of JNJ-63623872	AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.	Baseline up to Day 8
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-63623872	The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.	Baseline up to Day 8
Primary	Terminal Half-Life(t[1/2]) of JNJ-63623872	Terminal half-life (t[(1/2]) is defined as 0.693/Lambda(z).	Baseline up to Day 8
Primary	Rate Constant (Lambda[z])	Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.	Baseline up to Day 8
Primary	Apparent total body clearance (CL/F) of JNJ-63623872	Clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The CL/F will be calculated by dividing the dose by AUC (0-infinity).	Baseline up to Day 8
Primary	Apparent volume of distribution at the terminal Phase (Vd[z] /F) of JNJ-63623872	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.The Vd(z)/F will be calculated by dividing CL/F by lambda(z).	Baseline up to Day 8
Primary	Amount of JNJ-63623872 excreted in Urine (Ae[x-y])	Amount excreted into urine over a given time interval, calculated from the urinary drug concentration of the collection interval x to y hours post dosing multiplied with the associated urine volume of the interval.	Baseline up to Day 8
Primary	Total Amount of JNJ-63623872 excreted in Urine (Ae[total])	Total amount excreted into urine, calculated by adding the amounts of the individual intervals together.	Baseline up to Day 8
Primary	Percentage of JNJ-63623872 dose excreted into urine	Percentage of the dose excreted into urine of the collection interval x to y hours post dosing, calculated as 100 x (Aex-y/Dose).	Baseline up to Day 8
Primary	Total Percentage of JNJ-63623872 dose excreted into urine	Total percentage of the dose excreted into urine, calculated as 100 * (Ae[total]/Dose).	Baseline up to Day 8
Primary	Renal clearance	Renal clearance calculated as Ae (total)/AUC (infinity).	Baseline up to Day 8