TriangleNCT02573259 · OUTCOME
Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- L
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1
What was measured
Steady state volume of distribution of PF-0680159 for IV dosing. Vss was calculated by CL\*MRT. CL was the clearance for IV dosing. MRT was the mean residence time calculated for a single IV dose as AUMCinf/AUCinf - (DOF/2). AUMCinf was the area under the moment curve from time 0 extrapolated to infinity. DOF was the duration of infusion. AUCinf was the area under the serum concentration time profile from time 0 extrapolated to infinity.
Analysis population: The PK parameter analysis population was defined as all enrolled participants in Part 1 who received study drug following IV administration and had sufficient information to estimate at least 1 of the pharmacokinetic (PK) parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants who had reportable parameter values of Vss.
Groups in this outcome
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
Part 1: PF-06801591 1 mg/kg (IV)
Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
Part 1: PF-06801591 3 mg/kg (IV)
Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
Part 1: PF-06801591 10 mg/kg (IV)
Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
| Group | Source count |
|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
| Part 1: PF-06801591 1 mg/kg (IV) | 8 |
| Part 1: PF-06801591 3 mg/kg (IV) | 8 |
| Part 1: PF-06801591 10 mg/kg (IV) | 7 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0 |
| Part 1: PF-06801591 1 mg/kg (IV) | 1 |
| Part 1: PF-06801591 3 mg/kg (IV) | 0 |
| Part 1: PF-06801591 10 mg/kg (IV) | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06801591 1 mg/kg (IV) | NA | NA | Not reported | Not reported | Geometric mean and geometric coefficient of variation were not reported for n \< 3. |
Cycle 4 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0 |
| Part 1: PF-06801591 1 mg/kg (IV) | 0 |
| Part 1: PF-06801591 3 mg/kg (IV) | 0 |
| Part 1: PF-06801591 10 mg/kg (IV) | 0 |
Complete source fields
- classes
- categories
- measurements
- comment
- Geometric mean and geometric coefficient of variation were not reported for n \< 3.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- 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
- units
- Participants
- title
- Cycle 4 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- units
- Participants
- description
- Steady state volume of distribution of PF-0680159 for IV dosing. Vss was calculated by CL\*MRT. CL was the clearance for IV dosing. MRT was the mean residence time calculated for a single IV dose as AUMCinf/AUCinf - (DOF/2). AUMCinf was the area under the moment curve from time 0 extrapolated to infinity. DOF was the duration of infusion. AUCinf was the area under the serum concentration time profile from time 0 extrapolated to infinity.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
- id
- OG000
- title
- Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
- description
- Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
- id
- OG001
- title
- Part 1: PF-06801591 1 mg/kg (IV)
- description
- Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
- id
- OG002
- title
- Part 1: PF-06801591 3 mg/kg (IV)
- description
- Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
- id
- OG003
- title
- Part 1: PF-06801591 10 mg/kg (IV)
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK parameter analysis population was defined as all enrolled participants in Part 1 who received study drug following IV administration and had sufficient information to estimate at least 1 of the pharmacokinetic (PK) parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants who had reportable parameter values of Vss.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1
- title
- Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1
- type
- SECONDARY
- unit Of Measure
- L
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Preserved source evidence · Not medical advice