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

Part of paid clinical trials in Neptune City, New Jersey.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01626651
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jun 30, 2012
Status verified
Jun 2013
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib and Ketoconazole

Primary Outcome Measure

Ibrutinib plasma concentrations after administration on Day 1 [ Time Frame: over 72 hours after dosing on Day 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-Neptune CityNew Jersey--

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