TriangleNCT01970865 · OUTCOME
Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 Following Multiple Oral Doses (Phase 1)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*hr/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- 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
Tau refers to the dosing interval, and it equals to 12 or 24 hours for BID or QD dosing, respectively. AUCtau was determined using linear/log trapezoidal method.
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.
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 | Source count |
|---|---|
| 10 mg QD (Phase 1) | 3 |
| 25 mg QD (Phase 1) | 3 |
| 50 mg QD (Phase 1) | 3 |
| 75 mg QD (Phase 1) | 12 |
| 100 mg QD (Phase 1) | 16 |
| 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
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 752.1 | 26 | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 1701 | 29 | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 3367 | 39 | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 4107 | 53 | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 5121 | 30 | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 6157 | 9 | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | NA | NA | Not reported | Not reported | Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 4480 and 12900 ng\*hr/mL, respectively. |
| 35 mg BID (Phase 1) | NA | NA | Not reported | Not reported | Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 2140 ng\*hr/mL. |
| 75 mg BID (Phase 1) | 3574 | 35 | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 4058 | 33 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 26
- value
- 752.1
- group Id
- OG001
- spread
- 29
- value
- 1701
- group Id
- OG002
- spread
- 39
- value
- 3367
- group Id
- OG003
- spread
- 53
- value
- 4107
- group Id
- OG004
- spread
- 30
- value
- 5121
- group Id
- OG005
- spread
- 9
- value
- 6157
- comment
- Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 4480 and 12900 ng\*hr/mL, respectively.
- group Id
- OG006
- spread
- NA
- value
- NA
- comment
- Summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 2140 ng\*hr/mL.
- group Id
- OG007
- spread
- NA
- value
- NA
- group Id
- OG008
- spread
- 35
- value
- 3574
- group Id
- OG009
- spread
- 33
- value
- 4058
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 16
- 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
- Tau refers to the dosing interval, and it equals to 12 or 24 hours for BID or QD dosing, respectively. AUCtau was determined using linear/log trapezoidal method.
- dispersion Type
- Geometric Coefficient of Variation
- 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
- GEOMETRIC_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.
- 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
- Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 Following Multiple Oral Doses (Phase 1)
- type
- SECONDARY
- unit Of Measure
- ng*hr/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice