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

NCT ID: NCT02835508

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

Participants will receive a single dose of 1 tablet of JNJ-56021927, 60 milligram (mg) on Day 1.

Group Type: EXPERIMENTAL

JNJ-56021927 60 Milligram

Intervention Type: DRUG

JNJ-56021927 60 mg oral tablet.

Treatment B

Participants will receive a single dose of JNJ-56021927, 120 mg (2 tablets\*60 mg) on Day 1.

Group Type: EXPERIMENTAL

JNJ-56021927 120 Milligram

Intervention Type: DRUG

JNJ-56021927 120 mg as 2 tablets of 60 mg.

Treatment C

Participants will receive a single dose of JNJ-56021927, 240 mg (4 tablets\*60 mg) on Day 1.

Group Type: EXPERIMENTAL

JNJ-56021927 240 Milligram

Intervention Type: DRUG

JNJ-56021927 240 mg as 4 tablets of 60 mg.

Interventions

JNJ-56021927 60 Milligram

JNJ-56021927 60 mg oral tablet.

Intervention Type: DRUG

JNJ-56021927 120 Milligram

JNJ-56021927 120 mg as 2 tablets of 60 mg.

Intervention Type: DRUG

JNJ-56021927 240 Milligram

JNJ-56021927 240 mg as 4 tablets of 60 mg.

Intervention Type: DRUG

Other Intervention Names

apalutamide; apalutamide; apalutamide

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Kumamoto, , Japan

Countries

Japan

Other Identifiers

56021927PCR1021

Identifier Type: OTHER

Identifier Source: secondary_id

CR108165

Identifier Type: -

Identifier Source: org_study_id