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NCT01105247 · OUTCOME

Food Effect Cohort Assessments

Safety of PCI-32765 in Chronic Lymphocytic Leukemia · Source last updated 2014-03-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Not reported
Interval / dispersion
90% Confidence Interval
Time frame
Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.

What was measured

Geometric mean ratio (Fed/Fasted) for PCI-32765 AUClast. The data were collected at 0, 0.5, 1, 2, 4, 6, 24 h post-dose. The AUClast was calculated from 0 up to 24 hours post-dose.

Analysis population: Note: 16 subjects were participated in food effect cohort. However, the PK parameters for 1 subject under Fasted treatment period cannot be reliably estimated. The data for this subject were excluded from Fed/Fasted comparison.

Groups in this outcome

Food Effect Cohort

PCI-32765: 420 mg daily

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Food Effect Cohort15

Reported measurements

Source class 1
Values in Not reported · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Food Effect Cohort1.65Not reported1.232.19Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.23
        upper Limit
        2.19
        value
        1.65
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Geometric mean ratio (Fed/Fasted) for PCI-32765 AUClast. The data were collected at 0, 0.5, 1, 2, 4, 6, 24 h post-dose. The AUClast was calculated from 0 up to 24 hours post-dose.
dispersion Type
90% Confidence Interval
groups
  1. description
    PCI-32765: 420 mg daily
    id
    OG000
    title
    Food Effect Cohort
param Type
NUMBER
population Description
Note: 16 subjects were participated in food effect cohort. However, the PK parameters for 1 subject under Fasted treatment period cannot be reliably estimated. The data for this subject were excluded from Fed/Fasted comparison.
reporting Status
POSTED
time Frame
Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.
title
Food Effect Cohort Assessments
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice