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A Crossover Study to Evaluate the Bioavailability of Ibrutinib Suspension and Sprinkle Formulations Compared to Capsules in Healthy Adults

NCT02390609 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-12-23

No results posted yet for this study

Summary

The purpose of this study is to assess the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of ibrutinib in healthy adults following single oral dose administration of suspension and sprinkle formulations under fed and fasted conditions compared with capsules under fasted conditions.

Conditions

  • Healthy

Interventions

DRUG

Ibrutinib (Treatment A) [Reference]

Participants will receive Ibrutinib 560 milligram (mg) (4\*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.

DRUG

Ibrutinib (Treatment B)

Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods.

DRUG

Ibrutinib (Treatment C)

Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods.

DRUG

Ibrutinib (Treatment D)

Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment D under fasted conditions in one of the treatment periods.

DRUG

Ibrutinib (Treatment E)

Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment E under fed (high-fat) conditions in one of the treatment periods.

DRUG

Ibrutinib (Treatment F)

Participants will receive Ibrutinib 560 mg sprinkle capsule granules suspended in water as Treatment F under fasted conditions in one of the treatment periods.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Belgium

Study Locations

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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 NCT02390609 on ClinicalTrials.gov