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A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants

NCT01626651 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2013-06-19

No results posted yet for this study

Summary

The purpose of this study is to assess the potential effects of ketoconazole on the pharmacokinetics of ibrutinib in healthy participants.

Conditions

  • Healthy

Interventions

DRUG

Ibrutinib

A single oral dose of 120 mg ibrutinib (3 x 40 mg capsules) on Day 1, and 40 mg (1x 40 mg capsule) ibrutinib on Day 7.

DRUG

Ketoconazole

Ketoconazole (400 mg \[2 x 200 mg\] once daily) will be orally administered on Days 4, 5, 6, 7, 8 and 9.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01626651 on ClinicalTrials.gov