TriangleNCT01970865 · OUTCOME
Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) 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*hour/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 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
Tau refers to the dosing interval, and it equals to 24 hours for QD dosing which was adopted in Phase 2. AUCtau was determined using linear/log trapezoidal method.
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, 'Number Analyzed' signifies participants evaluable for specified row.
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 | 5308 | 36 | 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 | 5650 | 39 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 36
- value
- 5308
- denoms
- counts
- group Id
- OG000
- value
- 19
- units
- Participants
- title
- Day -7
- categories
- measurements
- group Id
- OG000
- spread
- 39
- value
- 5650
- denoms
- counts
- group Id
- OG000
- value
- 22
- units
- Participants
- title
- Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 22
- units
- Participants
- description
- Tau refers to the dosing interval, and it equals to 24 hours for QD dosing which was adopted in Phase 2. AUCtau was determined using linear/log trapezoidal method.
- 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, 'Number Analyzed' signifies participants evaluable for specified row.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 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
- Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 (Phase 2)
- type
- SECONDARY
- unit Of Measure
- ng*hour/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice