Study to Investigate Effects of Repeated Administration of Itraconazole on Pharmacokinetics of JNJ-42847922 in Healthy Male Participants

NCT ID: NCT02455856

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-18
• Study Completion Date: 2015-06-19

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JNJ-42847922 plus Itraconazole

Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter \[mL\] oral solution on Day 1 and Day 6 and itraconazole as 200 mg (2\*100 mg capsule) from Day 2 to Day 6.

Group Type: EXPERIMENTAL

JNJ-42847922

Intervention Type: DRUG

Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter \[mL\] oral solution on Day 1 and Day 6.

Itraconazole

Intervention Type: DRUG

Participants will receive single dose of itraconazole as 200 mg (2\*100 mg capsule) from Day 2 to Day 6.

Interventions

JNJ-42847922

Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter \[mL\] oral solution on Day 1 and Day 6.

Intervention Type: DRUG

Itraconazole

Participants will receive single dose of itraconazole as 200 mg (2\*100 mg capsule) from Day 2 to Day 6.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Cilag N.V./S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Berlin, , Germany

Countries

Germany

Other Identifiers

42847922EDI1005

Identifier Type: OTHER

Identifier Source: secondary_id

2014-005499-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR107144

Identifier Type: -

Identifier Source: org_study_id