Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02841150
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • IMBRUVICA (Treatment A) — DRUG
    IMBRUVICA (reference treatment), 4\*140 milligram (mg), capsules.
  • Ibrutinib (Treatment B) — DRUG
    Ibrutinib (test treatment), 1\*560 mg, tablet.

Study Details

The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.

Key Dates

Start date
Jun 30, 2016
Status verified
Mar 2018
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
102 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Treatment Sequence 1
    Participants will receive treatment A, on Day 1 of Intervention Period 1 followed by treatment B , on Day 1 of Intervention Period 2 followed by treatment A, Day 1 of Intervention Period 3 and then followed by treatment B, on Day 1 of Intervention Period 4. Each intervention Period will be separated by a washout period of 7-9 days.
  • Experimental: Treatment Sequence 2
    Participants will receive treatment B, on Day 1 of Intervention Period 1 followed by treatment A, on Day 1 of Intervention Period 2 followed by treatment B, Day 1 of Intervention Period 3 and then followed by treatment A, on Day 1 of Intervention Period 4. Each intervention Period will be separated by a washout period of 7-9 days.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of Ibrutinib [ Time Frame: Day 1 (Pre-dose) up to Day 3 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-TempeArizona--

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