TriangleNCT03814005 · OUTCOME
Parts A, fu: Fraction of Unbound Drug in Plasma for Pevonedistat
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- percentage of plasma fraction unbound
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Analysis population: PK population included all participants who had sufficient dosing in Part A and Part B Cycle 1, had sufficient concentration-time data to permit reliable estimation of PK parameters, and who had not received any excluded concomitant medications through the completion of Part A. Overall number analyzed is the number of participants available for analyses.
Groups in this outcome
Part A: Control Arm: Pevonedistat 20 mg/m^2
Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).
Part A: Renal Arm: Pevonedistat 20 mg/m^2
Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).
Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2
Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with hematologic malignancies (MDS and AML).
| Group | Source count |
|---|---|
| Part A: Control Arm: Pevonedistat 20 mg/m^2 | 10 |
| Part A: Renal Arm: Pevonedistat 20 mg/m^2 | 4 |
| Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Control Arm: Pevonedistat 20 mg/m^2 | 5.800 | 18.2880 | Not reported | Not reported | Not reported |
| Part A: Renal Arm: Pevonedistat 20 mg/m^2 | 7.073 | 12.2269 | Not reported | Not reported | Not reported |
| Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 | 5.529 | 2.0462 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 18.2880
- value
- 5.800
- group Id
- OG001
- spread
- 12.2269
- value
- 7.073
- group Id
- OG002
- spread
- 2.0462
- value
- 5.529
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).
- id
- OG000
- title
- Part A: Control Arm: Pevonedistat 20 mg/m^2
- description
- Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).
- id
- OG001
- title
- Part A: Renal Arm: Pevonedistat 20 mg/m^2
- description
- Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with hematologic malignancies (MDS and AML).
- id
- OG002
- title
- Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2
- param Type
- GEOMETRIC_MEAN
- population Description
- PK population included all participants who had sufficient dosing in Part A and Part B Cycle 1, had sufficient concentration-time data to permit reliable estimation of PK parameters, and who had not received any excluded concomitant medications through the completion of Part A. Overall number analyzed is the number of participants available for analyses.
- reporting Status
- POSTED
- time Frame
- Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
- title
- Parts A, fu: Fraction of Unbound Drug in Plasma for Pevonedistat
- type
- SECONDARY
- unit Of Measure
- percentage of plasma fraction unbound
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice