Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02877225
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib (test treatment) 140 milligram (mg), tablet.
  • IMBRUVICA — DRUG
    IMBRUVICA (reference treatment), 140-mg capsule

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
Aug 29, 2016
Status verified
Mar 2017
Primary completion
Nov 11, 2016
Completion
Nov 11, 2016

Study Design

Enrollment
103 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Sequence 1 : ABAB
    Participants will receive 140 milligram (mg) of ibrutinib administered as one IMBRUVICA 140-mg oral capsule (Treatment A) in Period 1, 140 mg of ibrutinib administered as one ibrutinib 140-mg oral tablet (Treatment B) in Period 2, then Treatment A in period 3 and then followed by Treatment B in Period 4. Each intervention Period will be separated by a washout period of 7-9 days.
  • Experimental: Treatment Sequence 2 : BABA
    Participants will receive (Treatment B) Period 1, then Treatment A in Period 2, then Treatment B in Period 3 and then followed by Treatment A in Period 4. Each intervention Period will be separated by a washout period of 7-9 days.

Primary Outcome Measure

Area Under Concentration from time zero to the last quantifiable (AUC [0-last]) [ Time Frame: Predose up to Day 3 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-TempeArizona--

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