Pharmacokinetic Study of JNJ-56021927 When Taken Orally as Tablet Formulation in Healthy Male Japanese Participants

Healthy Clinical Trial

Official title:

A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Pharmacokinetic Profile of JNJ-56021927 When Administered as the Tablet Formulation in Healthy Male Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835508
• Other study ID #: CR108165
• Secondary ID: 56021927PCR1021
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2016
• Last updated: January 10, 2017
• Start date: June 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the safety and Pharmacokinetic (PK) profile of JNJ-56021927 and its active metabolite JNJ-56142060 after single-dose administration of 60 milligram (mg), 120 mg, and 240 mg JNJ-56021927 as the tablet formulation in healthy male Japanese participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Participant must have a body mass index between 18.0 and 29.9 Kilogram per meter square (kg/m^2), inclusive, and a body weight not less than 50 Kilogram (kg)

• Participant must have a blood pressure between 90 and 140 Millimeters of Mercury (mm Hg) systolic, inclusive, and no higher than 90 mm Hg diastolic at screening

• Participant must have a normal 12-lead Electrocardiogram (ECG) (based on the mean value of the triplicate parameters) consistent with normal cardiac conduction and function at screening, including: a) normal sinus rhythm (heart rate between 45 and 90 beats per minute, extremes included); b) QT interval corrected for heart rate according to Fridericia (QTcF) <= 450 milliseconds (ms); c) QRS interval less than or equal (<=)110 ms; d) PR interval <200 ms; e) ECG morphology consistent with healthy cardiac conduction and function

• Participant must be a healthy Japanese male

• Participant must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during intercourse and to not donate sperm during the study and for 3 months after study drug administration

Exclusion Criteria:

• Participant with a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

• Participant has donated blood or blood product or had substantial loss of blood more than 200 milliliter (mL) within 1 month before study drug administration, or greater than equal (>=) 400 mL within 3 months before study drug administration, or participant has donated a total volume of blood in the past one year exceeding 1200 mL, or participant has an intention to donate blood or blood products during the study and for at least 2 months after completion of the study

• Participant has presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc) or any medical condition that would affect sexual function

• Participant has received an investigational drug including investigational vaccines or used an invasive investigational medical device within 3 months or within a period less than 10 times the drug's half-life, whichever is longer, before the planned study drug administration

• Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-hepatitis C virus {HCV}) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-56021927 60 Milligram
JNJ-56021927 60 mg oral tablet.
• JNJ-56021927 120 Milligram
JNJ-56021927 120 mg as 2 tablets of 60 mg.
• JNJ-56021927 240 Milligram
JNJ-56021927 240 mg as 4 tablets of 60 mg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Maximum observed plasma concentration (Cmax) will be assessed.	Predose, Up to Day 57	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)	Actual sampling time to reach maximum observed analyte concentration (Tmax) will be assessed.	Predose, Up to Day 57	No
Primary	Area Under Concentration from time zero to the last quantifiable AUC (0-last)	AUC from time zero to the last quantifiable concentration will be assessed.	Predose, Up to Day 57	No
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])	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 (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. AUC (0-infinity) will be assessed.	Predose, Up to Day 57	No
Primary	Time to Last Quantifiable Plasma Concentration (Tlast)	The Tlast, time to last observed quantifiable plasma concentration will be assessed.	Predose, Up to Day 57	No
Primary	Percentage of Area Under the Plasma Concentration-Time Curve Extrapolated From Last Measurable Concentration to Infinite Time (%AUC,ext)	Percentage of area under the plasma concentration-time curve extrapolated from last measurable concentration to infinite time (%AUC,ext) is calculated as (AUC [0-infinity] minus AUC [0-last])/ AUC [0-infinity])*100.	Predose, Up to Day 57	No
Primary	Apparent Clearance (CL/F)	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F will be calculated as CL/F = Dose/AUC [0-infinity]	Predose, Up to Day 57	No
Primary	Apparent Terminal Elimination Half-life (t1/2term)	Apparent terminal elimination half-life, calculated as 0.693/apparent terminal elimination rate constant (?z)	Predose, Up to Day 57	No
Primary	Apparent Terminal Elimination Rate Constant (lambda z)	Apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs time data	Predose, Up to Day 57	No
Primary	Apparent Volume of Distribution (Vd/F)	Apparent volume of distribution based on the terminal phase following oral administration calculated as Vd/F = Dose/ apparent terminal elimination rate constant (?z)*AUC [0-infinity]	Predose, Up to Day 57	No
Primary	Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)	Metabolite to parent drug ratio for Cmax will be assessed.	Predose, Up to Day 57	No
Primary	Metabolite to Parent Drug Ratio for Area Under Concentration from time zero to the last quantifiable concentration (MPR AUC [0-last])	Metabolite to parent drug ratio for AUC [0-last] will be assessed.	Predose, Up to Day 57	No
Primary	Metabolite to Parent Drug Ratio for Area Under Curve from time zero extrapolated to infinity (MPR AUC [0-infinity])	Metabolite to parent drug ratio for AUC [0-infinity] will be assessed.	Predose, Up to Day 57	No
Primary	Area Under Curve from time of administration to 24 hours post dosing	AUC from time of administration to 24 hours post dosing will be assessed.	Predose, Up to Day 57	No
Primary	Area Under Curve from time of administration to 168 hours post dosing	AUC from time of administration to 168 hours post dosing will be assessed.	Predose, Up to Day 57	No
Secondary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability		Up to Day 57	No