TriangleNCT01970865 · OUTCOME
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Midazolam (Phase 1)
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
- Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15
What was measured
AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the rate constant for terminal phase. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.
Analysis population: PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.
Groups in this outcome
25 mg QD (Phase 1)
PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
150 mg QD (Phase 1)
PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
| Group | Source count |
|---|---|
| 25 mg QD (Phase 1) | 3 |
| 150 mg QD (Phase 1) | 3 |
Reported measurements
Day -7
| Group | Source count |
|---|---|
| 25 mg QD (Phase 1) | 3 |
| 150 mg QD (Phase 1) | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 25 mg QD (Phase 1) | 54.53 | 43 | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | NA | NA | Not reported | Not reported | Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 42.2 and 46.8 ng\*hr/mL, respectively. |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| 25 mg QD (Phase 1) | 3 |
| 150 mg QD (Phase 1) | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 25 mg QD (Phase 1) | 21.32 | 18 | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 16.09 | 29 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 43
- value
- 54.53
- comment
- Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 42.2 and 46.8 ng\*hr/mL, respectively.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Day -7
- categories
- measurements
- group Id
- OG000
- spread
- 18
- value
- 21.32
- group Id
- OG001
- spread
- 29
- value
- 16.09
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the rate constant for terminal phase. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
- id
- OG000
- title
- 25 mg QD (Phase 1)
- description
- PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
- id
- OG001
- title
- 150 mg QD (Phase 1)
- param Type
- GEOMETRIC_MEAN
- population Description
- PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 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 Extrapolated to Infinite Time (AUCinf) of Midazolam (Phase 1)
- type
- SECONDARY
- unit Of Measure
- ng*hr/mL
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Preserved source evidence · Not medical advice