TriangleNCT01970865 · OUTCOME
Apparent Volume of Distribution (Vz/F) 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
- Liters
- 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
Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug, and calculated as dose/(AUCinf\*kel), where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time, 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. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
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) | 229.0 | 7 | 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 161 and 486 L, 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) | 404.4 | 51 | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 702.2 | 100 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 7
- value
- 229.0
- comment
- Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 161 and 486 L, 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
- 51
- value
- 404.4
- group Id
- OG001
- spread
- 100
- value
- 702.2
- 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
- Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug, and calculated as dose/(AUCinf\*kel), where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time, 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. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
- 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
- Apparent Volume of Distribution (Vz/F) of Midazolam (Phase 1)
- type
- SECONDARY
- unit Of Measure
- Liters
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice