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

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ClinicalTrials.gov Identifier: NCT02065739
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-42165279 Drug: Itraconazole Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Potential Effects of Repeated Administration of Itraconazole on the Pharmacokinetics of JNJ-42165279 in Healthy Male Subjects
Study Start Date : January 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Period 1
Participants will receive a single 30-mg dose of JNJ-42165279 on Day 1.
Drug: JNJ-42165279
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).

Experimental: Period 2
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
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).

Drug: Itraconazole
Participants will receive itraconazole 200 mg (2 capsules) once a day orally on Days 4, 5, 6, 7, 8, 9, and 10 (Period 2).




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of JNJ-42165279 [ Time Frame: 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 ]
    The Cmax is defined as maximum observed analyte concentration.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-42165279 [ Time Frame: 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 ]
    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  3. Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUCt) of JNJ-42165279 [ Time Frame: 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 ]
    AUCt is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.

  4. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])of JNJ-42165279 [ Time Frame: 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 ]
    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.

  5. Terminal Rate Constant (Lambda[z]) of JNJ-42165279 [ Time Frame: 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 ]
    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.

  6. Elimination Half-Life Period (T1/2) of JNJ-42165279 [ Time Frame: 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 ]
    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).

  7. Relative Bioavailability (Frel) of JNJ-42165279 [ Time Frame: 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 is the percentage of the administered dose that is systemically available.


Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to Week 7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065739


Locations
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Belgium
Merksem, Belgium
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
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Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial Janssen Pharmaceutica N.V., Belgium

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Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT02065739     History of Changes
Other Study ID Numbers: CR103432
42165279EDI1004 ( Other Identifier: Janssen Pharmaceutica N.V., Belgium )
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014
Keywords provided by Janssen Pharmaceutica N.V., Belgium:
Healthy
JNJ-42165279
Itraconazole
Pharmacokinetics
Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors