TriangleNCT03685591 · OUTCOME
Apparent Volume of Distribution (Vz/F) of PF-06952229 (Part 1B)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Liter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 of cycle 1 and cycle 2
What was measured
Vz/F was defined as apparent volume of distribution. Vz/F = Dose / (AUCinf\* kel) for single dose; Vz/F = Dose / (AUCtau\* kel) for steady-state. AUCtau was defined as Area under the plasma concentration-time profile from time zero to time tau (τ), the dosing interval, where τ = 24 and 12 hours for QD and BID dosing, respectively. Kel was defined as terminal phase rate constant.
Analysis population: Participants with mCRPC, conducted dose escalation of PF-06952229 in combination with enzalutamide, who had sufficient information to estimate at least 1 of the PK parameters of interest and contributed to the summary statistics for Vz/F. Vz/F can be evaluated only when a well characterized terminal phase was observed, which is defined as one with at least 3 data points, r\^2≥0.9, and AUCextrap%≤20. Here, "number analyzed" signifies participant evaluable for each row.
Groups in this outcome
Part 1B: PF-06952229 250mg + Enzalutamide
PF-06952229 was administered at a dose of 250 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally once a day (QD) as continuous daily dosing.
Part 1B: PF-06952229 375mg + Enzalutamide
PF-06952229 was administered at a dose of 375 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally QD as continuous daily dosing.
| Group | Source count |
|---|---|
| Part 1B: PF-06952229 250mg + Enzalutamide | 2 |
| Part 1B: PF-06952229 375mg + Enzalutamide | 2 |
Reported measurements
Cycle 1 Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1B: PF-06952229 250mg + Enzalutamide | 161.8 | 14 | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 228.4 | 4 | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1B: PF-06952229 250mg + Enzalutamide | 372.4 | 67 | Not reported | Not reported | Not reported |
| Part 1B: PF-06952229 375mg + Enzalutamide | 408.7 | 11 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 14
- value
- 161.8
- group Id
- OG001
- spread
- 4
- value
- 228.4
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 67
- value
- 372.4
- group Id
- OG001
- spread
- 11
- value
- 408.7
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- Vz/F was defined as apparent volume of distribution. Vz/F = Dose / (AUCinf\* kel) for single dose; Vz/F = Dose / (AUCtau\* kel) for steady-state. AUCtau was defined as Area under the plasma concentration-time profile from time zero to time tau (τ), the dosing interval, where τ = 24 and 12 hours for QD and BID dosing, respectively. Kel was defined as terminal phase rate constant.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- PF-06952229 was administered at a dose of 250 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally once a day (QD) as continuous daily dosing.
- id
- OG000
- title
- Part 1B: PF-06952229 250mg + Enzalutamide
- description
- PF-06952229 was administered at a dose of 375 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally QD as continuous daily dosing.
- id
- OG001
- title
- Part 1B: PF-06952229 375mg + Enzalutamide
- param Type
- GEOMETRIC_MEAN
- population Description
- Participants with mCRPC, conducted dose escalation of PF-06952229 in combination with enzalutamide, who had sufficient information to estimate at least 1 of the PK parameters of interest and contributed to the summary statistics for Vz/F. Vz/F can be evaluated only when a well characterized terminal phase was observed, which is defined as one with at least 3 data points, r\^2≥0.9, and AUCextrap%≤20. Here, "number analyzed" signifies participant evaluable for each row.
- reporting Status
- POSTED
- time Frame
- 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 of cycle 1 and cycle 2
- title
- Apparent Volume of Distribution (Vz/F) of PF-06952229 (Part 1B)
- type
- SECONDARY
- unit Of Measure
- Liter
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Preserved source evidence · Not medical advice