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A Study to Determine the Effect of Food on the Pharmacokinetics of PCI-32765

NCT01820936 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2014-07-15

No results posted yet for this study

Summary

The purpose of this study is to compare the effect of food and two modified fasting regimens on the pharmacokinetics (study of what the body does to a drug) of PCI-32765 in healthy adult participants.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Sequence 1: PCI-32765

Period 1 = Treatment D, Period 2 = Treatment C, Period 3 = Treatment A, Period 4 = Treatment B

DRUG

Sequence 2: PCI-32765

Period 1 = Treatment A, Period 2 = Treatment D, Period 3 = Treatment B, Period 4 = Treatment C

DRUG

Sequence 3: PCI-32765

Period 1 = Treatment B, Period 2 = Treatment A, Period 3 = Treatment C, Period 4 = Treatment D

DRUG

Sequence 4: PCI-32765

Period 1 = Treatment C, Period 2 = Treatment B, Period 3 = Treatment D, Period 4 = Treatment A

DRUG

Sequence 5: PCI-32765

After completion of the 4-way crossover, an additional separate cohort of 8 subjects were enrolled. These subjects participated in 1 treatment period to document safety and PK

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
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-06-30
Completion
2013-06-30

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 NCT01820936 on ClinicalTrials.gov