NCT01970865 · OUTCOME

Observed Accumulation Ratio (Rac) of PF-06463922 Following Multiple Oral Doses (Phase 1)

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

Measure: MEAN
Unit: Ratio
Interval / dispersion: Standard Deviation
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)

What was measured

Rac was calculated as Day 15 AUCtau/Day -7 AUCtau or Day 1 AUCtau, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (12 and 24 hours for BID and QD dosing regimen, respectively).

Analysis population: PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Groups in this outcome

10 mg QD (Phase 1)

PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

25 mg QD (Phase 1)

PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.

50 mg QD (Phase 1)

PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

75 mg QD (Phase 1)

PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

100 mg QD (Phase 1)

PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

150 mg QD (Phase 1)

PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.

200 mg QD (Phase 1)

PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

35 mg BID (Phase 1)

PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

75 mg BID (Phase 1)

PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

100 mg BID (Phase 1)

PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.

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
10 mg QD (Phase 1)	3
25 mg QD (Phase 1)	3
50 mg QD (Phase 1)	2
75 mg QD (Phase 1)	12
100 mg QD (Phase 1)	15
150 mg QD (Phase 1)	3
200 mg QD (Phase 1)	2
35 mg BID (Phase 1)	1
75 mg BID (Phase 1)	3
100 mg BID (Phase 1)	3

Reported measurements

Source class 1

Values in Ratio · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
10 mg QD (Phase 1)	1.543	0.075056	Not reported	Not reported	Not reported
25 mg QD (Phase 1)	1.237	0.20817	Not reported	Not reported	Not reported
50 mg QD (Phase 1)	1.105	NA	Not reported	Not reported	Standard deviation was not calculated when fewer than 3 participants had reportable values.
75 mg QD (Phase 1)	1.121	0.44575	Not reported	Not reported	Not reported
100 mg QD (Phase 1)	1.071	0.31138	Not reported	Not reported	Not reported
150 mg QD (Phase 1)	1.000	0.79137	Not reported	Not reported	Not reported
200 mg QD (Phase 1)	0.6500	NA	Not reported	Not reported	Standard deviation was not calculated when fewer than 3 participants had reportable values.
35 mg BID (Phase 1)	NA	NA	Not reported	Not reported	These summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 2.09.
75 mg BID (Phase 1)	1.231	0.35228	Not reported	Not reported	Not reported
100 mg BID (Phase 1)	1.523	0.29569	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.075056
value
1.543
group Id
OG001
spread
0.20817
value
1.237
comment
Standard deviation was not calculated when fewer than 3 participants had reportable values.
group Id
OG002
spread
NA
value
1.105
group Id
OG003
spread
0.44575
value
1.121
group Id
OG004
spread
0.31138
value
1.071
group Id
OG005
spread
0.79137
value
1.000
comment
Standard deviation was not calculated when fewer than 3 participants had reportable values.
group Id
OG006
spread
NA
value
0.6500
comment
These summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 2.09.
group Id
OG007
spread
NA
value
NA
group Id
OG008
spread
0.35228
value
1.231
group Id
OG009
spread
0.29569
value
1.523

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
12
group Id
OG004
value
15
group Id
OG005
value
3
group Id
OG006
value
2
group Id
OG007
value
1
group Id
OG008
value
3
group Id
OG009
value
3
units
Participants

description

dispersion Type

Standard Deviation

groups

description
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG000
title
10 mg QD (Phase 1)
description
PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
id
OG001
title
25 mg QD (Phase 1)
description
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG002
title
50 mg QD (Phase 1)
description
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG003
title
75 mg QD (Phase 1)
description
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG004
title
100 mg QD (Phase 1)
description
PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
id
OG005
title
150 mg QD (Phase 1)
description
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG006
title
200 mg QD (Phase 1)
description
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG007
title
35 mg BID (Phase 1)
description
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG008
title
75 mg BID (Phase 1)
description
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG009
title
100 mg BID (Phase 1)

param Type

MEAN

population Description

PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)

title

Observed Accumulation Ratio (Rac) of PF-06463922 Following Multiple Oral Doses (Phase 1)

type

SECONDARY

unit Of Measure

Ratio

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