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

NCT02448004 | Completed Phase 1

• 3 other identifiers: CR10730163623872FLZ10072015-000719-42
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; JNJ-63623872; 14C-JNJ-63623872

Outcome Measures

Primary Outcomes (13)

• Maximum Plasma Concentration (Cmax) of JNJ-63623872

  The Cmax is the maximum plasma concentration.

  Baseline up to Day 8

• Time to reach maximum concentration (tmax) of JNJ-63623872

  The Tmax is time to reach the maximum plasma concentration.

  Baseline up to Day 8

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Renal clearance

  Renal clearance calculated as Ae (total)/AUC (infinity).

  Baseline up to Day 8

Study Arms (1)

JNJ-63623872

EXPERIMENTAL

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

Drug: JNJ-63623872

Interventions

JNJ-63623872 DRUG

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

Also known as: 14C-JNJ-63623872

JNJ-63623872

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Cilag N.V./S.A.: lead

Study Sites (1)

Unknown Facility

Groningen, Netherlands

Location

MeSH Terms

Interventions

pimodivir

Study Officials

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

  Janssen Cilag N.V./S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 19, 2015
• Study Start: May 11, 2015
• Primary Completion: June 24, 2015
• Study Completion: June 24, 2015
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

NL (1)