NCT00652626 · OUTCOME

Time to Maximum Plasma Concentration of Azacitidine (Tmax) After Single and Multiple Doses of Azacitidine

Pharmacokinetics and Safety Study of Azacitidine in Cancer Patients With and Without Impaired Renal Function · Source last updated 2019-11-19

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

Measure: MEDIAN
Unit: hours
Interval / dispersion: Full Range
Time frame: Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose

What was measured

The time to first maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment.

Analysis population: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.

Groups in this outcome

Normal RF: Azacitidine 75 mg/m^2

Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.

Severe RI: Azacitidine 75 mg/m^2

Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.

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

Analysis denominator · Participants

Group	Source count
Normal RF: Azacitidine 75 mg/m^2	6
Severe RI: Azacitidine 75 mg/m^2	6

Reported measurements

Day 1

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Normal RF: Azacitidine 75 mg/m^2	0.25	Not reported	0.25	0.50	Not reported
Severe RI: Azacitidine 75 mg/m^2	0.50	Not reported	0.25	1.50	Not reported

Day 5

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Normal RF: Azacitidine 75 mg/m^2	0.38	Not reported	0.25	0.50	Not reported
Severe RI: Azacitidine 75 mg/m^2	0.64	Not reported	0.25	1.03	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
0.52
estimate Comment
Median difference is Severe RI - Normal RF.
group Description
Comparison of Tmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.1342
param Type
Median Difference (Final Values)
param Value
0.25
statistical Method
Wilcoxon (Mann-Whitney)
ci Lower Limit
0
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
0.50
estimate Comment
Median difference is Severe RI - Normal RF.
group Description
Comparison of Tmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.1017
param Type
Median Difference (Final Values)
param Value
0.25
statistical Method
Wilcoxon (Mann-Whitney)

Complete source fields

analyses

ci Lower Limit
0
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
0.52
estimate Comment
Median difference is Severe RI - Normal RF.
group Description
Comparison of Tmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.1342
param Type
Median Difference (Final Values)
param Value
0.25
statistical Method
Wilcoxon (Mann-Whitney)
ci Lower Limit
0
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
0.50
estimate Comment
Median difference is Severe RI - Normal RF.
group Description
Comparison of Tmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.1017
param Type
Median Difference (Final Values)
param Value
0.25
statistical Method
Wilcoxon (Mann-Whitney)

classes

categories
measurements
group Id
OG000
lower Limit
0.25
upper Limit
0.50
value
0.25
group Id
OG001
lower Limit
0.25
upper Limit
1.50
value
0.50
title
Day 1
categories
measurements
group Id
OG000
lower Limit
0.25
upper Limit
0.50
value
0.38
group Id
OG001
lower Limit
0.25
upper Limit
1.03
value
0.64
title
Day 5

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
6
units
Participants

description

The time to first maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment.

dispersion Type

Full Range

groups

description
Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
id
OG000
title
Normal RF: Azacitidine 75 mg/m^2
description
Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
id
OG001
title
Severe RI: Azacitidine 75 mg/m^2

param Type

MEDIAN

population Description

Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.

reporting Status

POSTED

time Frame

Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose

title

Time to Maximum Plasma Concentration of Azacitidine (Tmax) After Single and Multiple Doses of Azacitidine

type

PRIMARY

unit Of Measure

hours

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice