A Drug Interaction Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02638116
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib will be administered at a dose of 560 milligram (mg) orally (4 x 140 mg capsules) on Day 1 and Day 7.
  • Omeprazole — DRUG
    Omeprazole will be administered at dose of 40 mg tablets orally once daily from Day 3 to Day 7.

Study Details

The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults.

Key Dates

Start date
Jan 31, 2016
Status verified
Jan 2025
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

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

Arms

  • Experimental: Ibrutinib + Omeprazole
    Participants will receive a dose of Ibrutinib 560 milligram (mg) orally (4 x 140 mg capsules) on Day 1 and Day 7 and Omeprazole at a dose of 40 mg tablets orally once on Days 3 through 7.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of Ibrutinib [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7 ]

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