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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Itraconazole; Drug: JNJ-42165279

Study type: Interventional

Funder types: Industry

Identifiers

NCT02065739

42165279EDI1004 (Other Identifier)

CR103432

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Period 1

Experimental group

Description:

Participants will receive a single 30-mg dose of JNJ-42165279 on Day 1.

Treatment:

Drug: JNJ-42165279

Period 2

Experimental group

Description:

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.

Treatment:

Drug: JNJ-42165279

Drug: Itraconazole