A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of JNJ-42165279 in Healthy Male Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the effects of repeated administration of 200 mg of itraconazole on the single-dose pharmacokinetics of JNJ-42165279 in healthy male participants.

Detailed Description
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This is an open-label (all people know the identity of the intervention), study in healthy male participants. This study will consist of a screening phase (between 21 and 2 days prior to the first dose administration of JNJ-42165279), a 2-period (Period 1: Day 1 to Day 3 and Period 2: Day 4 to Day 10) open-label treatment phase, and a follow-up phase (within 7 to 14 days after the last dose of JNJ-42165279). A single 30-mg dose of JNJ-42165279 will be administered on Day 1 of Period 1. During Period 2, the administration of oral itraconazole 200 mg once a day will start on Day 4. A second single oral 30-mg dose of JNJ-42165279 will be administered on Day 8 together with the dose of 200 mg itraconazole. Sixteen healthy participants will be enrolled in this study. Safety assessments will include assessment of adverse events, supine vital signs, 12-lead electrocardiogram, clinical laboratory testing and physical examinations. The maximum study duration for each participant will be approximately 7 weeks.

Official Title
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A Study to Investigate the Potential Effects of Repeated Administration of Itraconazole on the Pharmacokinetics of JNJ-42165279 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: JNJ-42165279
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) between 18 and 30 kg/m2 inclusive (BMI = weight/height2) Nonsmoker (not smoked for 3 months prior to screening) During the study and for 3 months after receiving study medication, must agree to use an adequate contraception method (eg, vasectomy, double-barrier, partner using effective contraception), always use a condom during sexual intercourse and to not donate sperm Participants must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions Exclusion Criteria: Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram at screening or on Day 1, predose History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection. History of epilepsy or fits or unexplained black-outs Drinks, on average, more than 8 cups (more than or equal to 150 mL) of caffeine containing beverages per day Clinically significant acute illness within 7 days prior to study drug administration Has a contraindication to the use of itraconazole or any antifungal azoles

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1<br>Participants will receive a single 30-mg dose of JNJ-42165279 on Day 1. | Drug: JNJ-42165279<br>* Participants will receive a single 30-mg (6 mL of oral suspension) dose of JNJ-42165279 orally (by mouth) on Day 1 (Period 1) and on Day 8 (Period 2).<br>|
| Experimental: Period 2<br>Participants will receive itraconazole 200 mg once a day from Day 4 to Day 10. A single oral 30-mg dose of JNJ-42165279 will be administered on Day 8 along with the dose of 200 mg itraconazole. | Drug: JNJ-42165279<br>* Participants will receive a single 30-mg (6 mL of oral suspension) dose of JNJ-42165279 orally (by mouth) on Day 1 (Period 1) and on Day 8 (Period 2).<br>Drug: Itraconazole<br>* Participants will receive itraconazole 200 mg (2 capsules) once a day orally on Days 4, 5, 6, 7, 8, 9, and 10 (Period 2).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-42165279 | The Cmax is defined as maximum observed analyte concentration. | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-42165279 | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 | 
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUCt) of JNJ-42165279 | AUCt is area under the plasma concentration-time curve from time zero to the last quantifiable concentration. | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 | 
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])of JNJ-42165279 | The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration. | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 | 
| Terminal Rate Constant (Lambda[z]) of JNJ-42165279 | Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points. | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 | 
| Elimination Half-Life Period (T1/2) of JNJ-42165279 | The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 | 
| Relative Bioavailability (Frel) of JNJ-42165279 | Relative bioavailability is the percentage of the administered dose that is systemically available. | Day 1 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 2 (24, 36 hours), Day 3, Day 4, Day 8 (Pre-dose and post-dose 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, hours), Day 9 (24, 36 hours), Day 10, and Day 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability |  | Up to Week 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, JNJ-42165279, Itraconazole, Pharmacokinetics