TriangleNCT01832727 · OUTCOME
Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Apparent Volume of Distribution After Oral Administration (Vz/F) on Cycle 1, Day 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1
What was measured
The apparent volume of distribution after oral administration (Vz/F) calculated as the dose divided by AUCinf times ƒz, where ƒz was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase. PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2
Analysis population: Safety population
Groups in this outcome
180 mg Oprozomib Tablet
Participants who were administered 180 mg oprozomib tablets.
210 mg Oprozomib Tablet
Participants who were administered 210 mg oprozomib tablets.
240 mg Oprozomib Tablet
Participants who were administered 240 mg oprozomib tablets.
270 mg Oprozomib Tablet
Participants who were administered 270 mg oprozomib tablets.
300 mg Oprozomib Tablet
Participants who were administered 300 mg oprozomib tablets.
150 mg Oprozomib ER Tablet
Participants who were administered 150 mg extended release oprozomib tablets.
300 mg Oprozomib ER Tablet
Participants who were administered 300 mg extended release oprozomib tablets.
330 mg Oprozomib ER Tablet
Participants who were administered 330 mg extended release oprozomib tablets.
| Group | Source count |
|---|---|
| 180 mg Oprozomib Tablet | 7 |
| 210 mg Oprozomib Tablet | 6 |
| 240 mg Oprozomib Tablet | 4 |
| 270 mg Oprozomib Tablet | 4 |
| 300 mg Oprozomib Tablet | 5 |
| 150 mg Oprozomib ER Tablet | 1 |
| 300 mg Oprozomib ER Tablet | 15 |
| 330 mg Oprozomib ER Tablet | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 180 mg Oprozomib Tablet | 264000 | 235.6 | Not reported | Not reported | Not reported |
| 210 mg Oprozomib Tablet | 108000 | 106.7 | Not reported | Not reported | Not reported |
| 240 mg Oprozomib Tablet | 154000 | 79.5 | Not reported | Not reported | Not reported |
| 270 mg Oprozomib Tablet | 168000 | 138.9 | Not reported | Not reported | Not reported |
| 300 mg Oprozomib Tablet | 231000 | 54.7 | Not reported | Not reported | Not reported |
| 150 mg Oprozomib ER Tablet | NA | NA | Not reported | Not reported | calculation not performed for a single participant. |
| 300 mg Oprozomib ER Tablet | 161000 | 69.0 | Not reported | Not reported | Not reported |
| 330 mg Oprozomib ER Tablet | 178000 | 44.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 235.6
- value
- 264000
- group Id
- OG001
- spread
- 106.7
- value
- 108000
- group Id
- OG002
- spread
- 79.5
- value
- 154000
- group Id
- OG003
- spread
- 138.9
- value
- 168000
- group Id
- OG004
- spread
- 54.7
- value
- 231000
- comment
- calculation not performed for a single participant.
- group Id
- OG005
- spread
- NA
- value
- NA
- group Id
- OG006
- spread
- 69.0
- value
- 161000
- group Id
- OG007
- spread
- 44.3
- value
- 178000
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 15
- group Id
- OG007
- value
- 4
- units
- Participants
- description
- The apparent volume of distribution after oral administration (Vz/F) calculated as the dose divided by AUCinf times ƒz, where ƒz was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase. PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants who were administered 180 mg oprozomib tablets.
- id
- OG000
- title
- 180 mg Oprozomib Tablet
- description
- Participants who were administered 210 mg oprozomib tablets.
- id
- OG001
- title
- 210 mg Oprozomib Tablet
- description
- Participants who were administered 240 mg oprozomib tablets.
- id
- OG002
- title
- 240 mg Oprozomib Tablet
- description
- Participants who were administered 270 mg oprozomib tablets.
- id
- OG003
- title
- 270 mg Oprozomib Tablet
- description
- Participants who were administered 300 mg oprozomib tablets.
- id
- OG004
- title
- 300 mg Oprozomib Tablet
- description
- Participants who were administered 150 mg extended release oprozomib tablets.
- id
- OG005
- title
- 150 mg Oprozomib ER Tablet
- description
- Participants who were administered 300 mg extended release oprozomib tablets.
- id
- OG006
- title
- 300 mg Oprozomib ER Tablet
- description
- Participants who were administered 330 mg extended release oprozomib tablets.
- id
- OG007
- title
- 330 mg Oprozomib ER Tablet
- param Type
- GEOMETRIC_MEAN
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- Day 1
- title
- Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Apparent Volume of Distribution After Oral Administration (Vz/F) on Cycle 1, Day 1
- type
- SECONDARY
- unit Of Measure
- mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice