Clinical trial NCT02455856: Study to Investigate Effects of Repeated Administration of Itraconazole on Pharmacokinetics of JNJ-42847922 in Healthy Male Participants
Official title: A Study to Investigate the Potential Effects of Repeated Administration of Itraconazole on the Pharmacokinetics of JNJ-42847922 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Itraconazole
JNJ-42847922
Lead sponsor: Janssen Cilag N.V./S.A.
Sponsor class: INDUSTRY
First posted: 2015-05-28
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effects of repeated once daily administration of 200 milligram (mg) of itraconazole (steady state) on the single-dose pharmacokinetics of JNJ 42847922 in healthy, male participants.

Detailed description: This is an open-label (all people know the identity of the intervention), fixed-sequence, single-center, single-dose study designed to assess the effects of steady-state itraconazole exposure on the pharmacokinetics of a single oral dose of JNJ 42847922 in healthy male participants. The duration of study will be approximately of 6 weeks per participant. The study consists of 3 parts: Screening (that is, 21 days before study commences on Day 1); Open-label Treatment (6 days); and Follow-up (7 to 14 days after last dose of study drug or early withdrawal).

All eligible participants will receive single oral doses of 5 milligram (mg) JNJ-42847922 on Day 1 and Day 6. A daily dose of 200 mg itraconazole will be administered from Day 2 to Day 6. Followed by an overnight fast of at least 8 hours participants will be administered with study treatment 30 minutes after light breakfast. Participants will not be allowed to have food until 4 hours of drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Healthy male participants aged between 18 and 55 years, inclusive
* Body mass index (BMI) between 18 and 30 kilogram/meter\^2 inclusive (BMI = weight/height\^2)
* Nonsmoker (not smoked for at least 3 months prior to screening)
* Men who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners should also use an appropriate method of birth control for at least the same duration
* 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 ECG at screening, on Day -1 or on Day 1, predose
* History of or current significant psychiatric and other 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, or any other illness that the Investigator considers should exclude the subject. History of epilepsy or fits or unexplained black-outs
* Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV) or human immunodeficiency virus (HIV) antibodies
* History of clinically significant drug and/or food allergies

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of JNJ-42847922
timeFrame: up to Day 6
measure: Time to Reach Maximum Concentration (tmax) of JNJ-42847922
timeFrame: up to Day 6
measure: Time to Reach Last Quantifiable Plasma Concentration (tlast) of JNJ-42847922
timeFrame: up to Day 6
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-42847922
timeFrame: up to Day 6
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-42847922
timeFrame: up to Day 6
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24]) of JNJ-42847922
timeFrame: up to Day 6
measure: Elimination Half-Life (t [1/2] Lambda) of JNJ-42847922
timeFrame: up to Day 6
measure: Rate Constant (Lambda[z])
timeFrame: up to Day 6
measure: Apparent total body clearance (CL/F) of JNJ-42847922
timeFrame: up to Day 6
measure: Apparent volume of distribution at the terminal Phase (Vd[z] /F) of JNJ-42847922
timeFrame: up to Day 6
measure: Mean Residence Time of JNJ-42847922
timeFrame: up to Day 6
measure: Amount of JNJ-42847922 Excreted in Urine (Ae)
timeFrame: up to Day 6
measure: Percentage of JNJ-42847922 Dose Excreted in Urine
timeFrame: up to Day 6
measure: Renal Clearance
timeFrame: up to Day 6
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: up to End of study (7 to 14 days after lasr dose of study drug or early withdrawal)
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
References: