TriangleNCT01970865 · OUTCOME
Steady State Accumulation Ratio (Rss) 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
- 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
Rss was calculated as Day 15 AUCtau/Day -7 AUCinf, 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), and AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
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.
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.
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) | 1 |
| 50 mg QD (Phase 1) | 2 |
| 75 mg QD (Phase 1) | 11 |
| 100 mg QD (Phase 1) | 14 |
| 200 mg QD (Phase 1) | 2 |
| 35 mg BID (Phase 1) | 1 |
| 75 mg BID (Phase 1) | 1 |
| 100 mg BID (Phase 1) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (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 0.993. |
| 50 mg QD (Phase 1) | 0.5600 | NA | Not reported | Not reported | Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 0.401 and 0.719, respectively. |
| 75 mg QD (Phase 1) | 0.6131 | 0.29021 | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 0.6603 | 0.18604 | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 0.3935 | NA | Not reported | Not reported | Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 0.384 and 0.403, respectively. |
| 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 0.815. |
| 75 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 0.542. |
| 100 mg BID (Phase 1) | 0.7687 | 0.13552 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- These summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 0.993.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 0.401 and 0.719, respectively.
- group Id
- OG001
- spread
- NA
- value
- 0.5600
- group Id
- OG002
- spread
- 0.29021
- value
- 0.6131
- group Id
- OG003
- spread
- 0.18604
- value
- 0.6603
- comment
- Standard deviation was not calculated when fewer than 3 participants had reportable values. Individual values are 0.384 and 0.403, respectively.
- group Id
- OG004
- spread
- NA
- value
- 0.3935
- comment
- These summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 0.815.
- group Id
- OG005
- spread
- NA
- value
- NA
- comment
- These summary statistics were not calculated when fewer than 3 participants had reportable values. The individual value is 0.542.
- group Id
- OG006
- spread
- NA
- value
- NA
- group Id
- OG007
- spread
- 0.13552
- value
- 0.7687
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- units
- Participants
- description
- Rss was calculated as Day 15 AUCtau/Day -7 AUCinf, 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), and AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
- 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 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
- OG001
- 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
- OG002
- 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
- OG003
- title
- 100 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
- OG004
- 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
- OG005
- 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
- OG006
- 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
- OG007
- 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
- Steady State Accumulation Ratio (Rss) of PF-06463922 Following Multiple Oral Doses (Phase 1)
- type
- SECONDARY
- unit Of Measure
- Ratio
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Preserved source evidence · Not medical advice