TriangleNCT01970865 · OUTCOME
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) 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
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of midazolam was determined using linear/log trapezoidal method. 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 | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 25 mg QD (Phase 1) | 51.30 | 47 | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 36.49 | 20 | Not reported | Not reported | Not reported |
Cycle 1 Day 15
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 25 mg QD (Phase 1) | 20.43 | 18 | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 14.44 | 25 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 47
- value
- 51.30
- group Id
- OG001
- spread
- 20
- value
- 36.49
- title
- Day -7
- categories
- measurements
- group Id
- OG000
- spread
- 18
- value
- 20.43
- group Id
- OG001
- spread
- 25
- value
- 14.44
- title
- Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of midazolam was determined using linear/log trapezoidal method. 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 to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam (Phase 1)
- type
- SECONDARY
- unit Of Measure
- ng*hr/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice