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A Pharmacokinetic Study in Healthy Participants to Assess the Pharmacokinetics and Safety of a Supratherapeutic Dose of PCI-32765 (Ibrutinib) Capsule and Solution Formulations Administered With Food

NCT01969266 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2014-02-13

No results posted yet for this study

Summary

The purpose of this study is to examine the exposure and safety of a supratherapeutic dose of PCI-32765 (ibrutinib) in healthy adult volunteers.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Treatment A: PCI-32765

840 mg capsule formulation administered by mouth on Day 1

DRUG

Treatment B: PCI-32765

840 mg solution formulation administered by mouth on Day 1

Sponsors & Collaborators

  • Pharmacyclics LLC.

    collaborator INDUSTRY

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

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 NCT01969266 on ClinicalTrials.gov