TriangleNCT03814005 · OUTCOME
Part A, AUClast: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Pevonedistat Following a Single Dose
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- h*ng/mL
- 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.
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 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Control Arm: Pevonedistat 20 mg/m^2 | 1120.759 | 73.3956 | Not reported | Not reported | Not reported |
| Part A: Renal Arm: Pevonedistat 20 mg/m^2 | 1267.523 | 22.1528 | Not reported | Not reported | Not reported |
| Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 | 1020.344 | 71.9314 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 73.3956
- value
- 1120.759
- group Id
- OG001
- spread
- 22.1528
- value
- 1267.523
- group Id
- OG002
- spread
- 71.9314
- value
- 1020.344
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- 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.
- reporting Status
- POSTED
- time Frame
- Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
- title
- Part A, AUClast: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Pevonedistat Following a Single Dose
- type
- PRIMARY
- unit Of Measure
- h*ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice