Clinical trial NCT02835508: Pharmacokinetic Study of JNJ-56021927 When Taken Orally as Tablet Formulation in Healthy Male Japanese Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2016-07-18
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Predose, Up to Day 57
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Predose, Up to Day 57
measure: Area Under Concentration from time zero to the last quantifiable AUC (0-last)
timeFrame: Predose, Up to Day 57
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
timeFrame: Predose, Up to Day 57
measure: Time to Last Quantifiable Plasma Concentration (Tlast)
timeFrame: Predose, Up to Day 57
measure: Percentage of Area Under the Plasma Concentration-Time Curve Extrapolated From Last Measurable Concentration to Infinite Time (%AUC,ext)
timeFrame: Predose, Up to Day 57
measure: Apparent Clearance (CL/F)
timeFrame: Predose, Up to Day 57
measure: Apparent Terminal Elimination Half-life (t1/2term)
timeFrame: Predose, Up to Day 57
measure: Apparent Terminal Elimination Rate Constant (lambda z)
timeFrame: Predose, Up to Day 57
measure: Apparent Volume of Distribution (Vd/F)
timeFrame: Predose, Up to Day 57
measure: Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)
timeFrame: Predose, Up to Day 57
measure: Metabolite to Parent Drug Ratio for Area Under Concentration from time zero to the last quantifiable concentration (MPR AUC [0-last])
timeFrame: Predose, Up to Day 57
measure: Metabolite to Parent Drug Ratio for Area Under Curve from time zero extrapolated to infinity (MPR AUC [0-infinity])
timeFrame: Predose, Up to Day 57
measure: Area Under Curve from time of administration to 24 hours post dosing
timeFrame: Predose, Up to Day 57
measure: Area Under Curve from time of administration to 168 hours post dosing
timeFrame: Predose, Up to Day 57
Secondary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to Day 57
Other outcomes:
Locations:
city: Kumamoto-Shi
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K. Clinical Trial
role: STUDY_DIRECTOR
References: