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Effect of Ketoconazole on the Pharmacokinetics of JNJ-38518168 in Healthy Volunteers

NCT01690286 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2013-07-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effects of repeated twice-daily administration of 200 mg ketoconazole on the steady-state pharmacokinetics of JNJ-38518168.

Conditions

  • Healthy

Interventions

DRUG

JNJ-38518168 3 mg

One oral daily dose of JNJ-38518168 3 mg for 25 days.

DRUG

JNJ-38518168 30 mg

One oral daily dose of JNJ-38518168 30 mg for 25 days.

DRUG

JNJ-38518168 10 mg

One oral daily dose of JNJ-38518168 10 mg for 25 days.

DRUG

Ketoconazole 200 mg

Oral doses of ketoconazole 200 mg every 12 hours, from Day 22 through Day 25.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

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 NCT01690286 on ClinicalTrials.gov