TriangleNCT02659631 · OUTCOME
Area Under the Curve From Time 0 Extrapolated to Infinity Time (AUCinf) of PF-06671008
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
- C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
What was measured
AUCinf was calculated as AUClast +(Clast\*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
Analysis population: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Groups in this outcome
PF-06671008 1.5 ng/kg IV
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 7.5 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
PF-06671008 20 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 50 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 100 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 200 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
PF-06671008 300 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
PF-06671008 400 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
PF-06671008 200 ng/kg SC
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
| Group | Source count |
|---|---|
| PF-06671008 1.5 ng/kg IV | 1 |
| PF-06671008 7.5 ng/kg IV | 2 |
| PF-06671008 20 ng/kg IV | 3 |
| PF-06671008 50 ng/kg IV | 2 |
| PF-06671008 100 ng/kg IV | 4 |
| PF-06671008 200 ng/kg IV | 5 |
| PF-06671008 300 ng/kg IV | 4 |
| PF-06671008 400 ng/kg IV | 3 |
| PF-06671008 200 ng/kg SC | 2 |
| PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV | 1 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| PF-06671008 1.5 ng/kg IV | 0 |
| PF-06671008 7.5 ng/kg IV | 0 |
| PF-06671008 20 ng/kg IV | 0 |
| PF-06671008 50 ng/kg IV | 2 |
| PF-06671008 100 ng/kg IV | 3 |
| PF-06671008 200 ng/kg IV | 3 |
| PF-06671008 300 ng/kg IV | 2 |
| PF-06671008 400 ng/kg IV | 2 |
| PF-06671008 200 ng/kg SC | 0 |
| PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PF-06671008 50 ng/kg IV | NA | NA | Not reported | Not reported | Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values. |
| PF-06671008 100 ng/kg IV | 47.09 | 41 | Not reported | Not reported | Not reported |
| PF-06671008 200 ng/kg IV | 90.35 | 19 | Not reported | Not reported | Not reported |
| PF-06671008 300 ng/kg IV | NA | NA | Not reported | Not reported | Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values. |
| PF-06671008 400 ng/kg IV | NA | NA | Not reported | Not reported | Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values. |
| PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV | NA | NA | Not reported | Not reported | Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values. |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| PF-06671008 1.5 ng/kg IV | 0 |
| PF-06671008 7.5 ng/kg IV | 0 |
| PF-06671008 20 ng/kg IV | 0 |
| PF-06671008 50 ng/kg IV | 0 |
| PF-06671008 100 ng/kg IV | 0 |
| PF-06671008 200 ng/kg IV | 0 |
| PF-06671008 300 ng/kg IV | 0 |
| PF-06671008 400 ng/kg IV | 0 |
| PF-06671008 200 ng/kg SC | 0 |
| PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV | 0 |
Complete source fields
- classes
- categories
- measurements
- comment
- Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
- group Id
- OG003
- spread
- NA
- value
- NA
- group Id
- OG004
- spread
- 41
- value
- 47.09
- group Id
- OG005
- spread
- 19
- value
- 90.35
- comment
- Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
- group Id
- OG006
- spread
- NA
- value
- NA
- comment
- Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
- group Id
- OG007
- spread
- NA
- value
- NA
- comment
- Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
- group Id
- OG009
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- units
- Participants
- title
- Cycle 1 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- units
- Participants
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 1
- units
- Participants
- description
- AUCinf was calculated as AUClast +(Clast\*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
- id
- OG000
- title
- PF-06671008 1.5 ng/kg IV
- description
- PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
- id
- OG001
- title
- PF-06671008 7.5 ng/kg IV
- description
- PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
- id
- OG002
- title
- PF-06671008 20 ng/kg IV
- description
- PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
- id
- OG003
- title
- PF-06671008 50 ng/kg IV
- description
- PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
- id
- OG004
- title
- PF-06671008 100 ng/kg IV
- description
- PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
- id
- OG005
- title
- PF-06671008 200 ng/kg IV
- description
- PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
- id
- OG006
- title
- PF-06671008 300 ng/kg IV
- description
- PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
- id
- OG007
- title
- PF-06671008 400 ng/kg IV
- description
- PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
- id
- OG008
- title
- PF-06671008 200 ng/kg SC
- description
- PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
- id
- OG009
- title
- PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
- param Type
- GEOMETRIC_MEAN
- population Description
- All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
- reporting Status
- POSTED
- time Frame
- C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
- title
- Area Under the Curve From Time 0 Extrapolated to Infinity Time (AUCinf) of PF-06671008
- type
- SECONDARY
- unit Of Measure
- ng.hr/mL
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Preserved source evidence · Not medical advice