TriangleNCT01970865 · OUTCOME
Maximum Observed Plasma Concentration (Cmax) of PF-06463922 (Phase 2)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15
What was measured
Maximum observed plasma concentration (Cmax) of PF-06463922 was observed directly from data.
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 Analyzed" signifies participants analyzed for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Groups in this outcome
Phase 2 and Japan LIC PK Analysis Set
PK parameters of PF-06463922 were determined for a small subset of Phase 2 participants and Japan LIC. These participants received PF-06463922 100 mg orally QD and were combined into 1 reporting group for PK analysis. Japan LIC was not included in single-dose PK analysis, ie, they did not contribute to Day -7 data.
| Group | Source count |
|---|---|
| Phase 2 and Japan LIC PK Analysis Set | 22 |
Reported measurements
Day -7
| Group | Source count |
|---|---|
| Phase 2 and Japan LIC PK Analysis Set | 19 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 and Japan LIC PK Analysis Set | 695.2 | 40 | Not reported | Not reported | Not reported |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| Phase 2 and Japan LIC PK Analysis Set | 22 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 and Japan LIC PK Analysis Set | 576.5 | 42 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 40
- value
- 695.2
- denoms
- counts
- group Id
- OG000
- value
- 19
- units
- Participants
- title
- Day -7
- categories
- measurements
- group Id
- OG000
- spread
- 42
- value
- 576.5
- denoms
- counts
- group Id
- OG000
- value
- 22
- units
- Participants
- title
- Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 22
- units
- Participants
- description
- Maximum observed plasma concentration (Cmax) of PF-06463922 was observed directly from data.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- PK parameters of PF-06463922 were determined for a small subset of Phase 2 participants and Japan LIC. These participants received PF-06463922 100 mg orally QD and were combined into 1 reporting group for PK analysis. Japan LIC was not included in single-dose PK analysis, ie, they did not contribute to Day -7 data.
- id
- OG000
- title
- Phase 2 and Japan LIC PK Analysis Set
- 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. Here, "Overall Number Analyzed" signifies participants analyzed for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15
- title
- Maximum Observed Plasma Concentration (Cmax) of PF-06463922 (Phase 2)
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice