TriangleNCT01478581 · OUTCOME
Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h).
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- h∙ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Procedure was performed up to 60 weeks.
What was measured
Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Ibrutinib AUC0-24h calculated using linear trapezoidal summation after dosing from time 0 to 24 hours on Day 8.
Analysis population: All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.
Groups in this outcome
Cohort 1
PCI-32765 420 mg per day PCI-32765
Cohort 2
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
Cohort 3
PCI-32765 840 mg per day PCI-32765
Cohort 4
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
| Group | Source count |
|---|---|
| Cohort 1 | 13 |
| Cohort 2 | 16 |
| Cohort 3 | 18 |
| Cohort 4 | 43 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 1094 | 808 | Not reported | Not reported | Not reported |
| Cohort 2 | 723 | 768 | Not reported | Not reported | Not reported |
| Cohort 3 | 1423 | 1014 | Not reported | Not reported | Not reported |
| Cohort 4 | 1230 | 1914 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 808
- value
- 1094
- group Id
- OG001
- spread
- 768
- value
- 723
- group Id
- OG002
- spread
- 1014
- value
- 1423
- group Id
- OG003
- spread
- 1914
- value
- 1230
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 43
- units
- Participants
- description
- Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Ibrutinib AUC0-24h calculated using linear trapezoidal summation after dosing from time 0 to 24 hours on Day 8.
- dispersion Type
- Standard Deviation
- groups
- description
- PCI-32765 420 mg per day PCI-32765
- id
- OG000
- title
- Cohort 1
- description
- PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
- id
- OG001
- title
- Cohort 2
- description
- PCI-32765 840 mg per day PCI-32765
- id
- OG002
- title
- Cohort 3
- description
- PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
- id
- OG003
- title
- Cohort 4
- param Type
- MEAN
- population Description
- All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.
- reporting Status
- POSTED
- time Frame
- Procedure was performed up to 60 weeks.
- title
- Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h).
- type
- SECONDARY
- unit Of Measure
- h∙ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice