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

NCT02065739 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-04-23

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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).

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica N.V., Belgium Clinical Trial · Janssen Pharmaceutica N.V., Belgium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02065739 on ClinicalTrials.gov