TriangleNCT01794520 · OUTCOME
Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to 24 Hours (AUC0-24) of Venetoclax
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- µg•h/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose (dose escalation cohort); (1200 mg dose): Cycle 2, Day 1 at predose (safety expansion cohort, 1200 mg dose)
What was measured
AUC is a measure of how long and how much drug is present in the body after dosing.
Analysis population: Phase 1 dose escalation and safety expansion participants with available data
Groups in this outcome
300 mg Venetoclax
Participants who received a 300 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
600 mg Venetoclax
Participants who received a 600 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
900 mg Venetoclax
Participants who received a 900 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
1200 mg Venetoclax
Participants who received a 1200 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
| Group | Source count |
|---|---|
| 300 mg Venetoclax | 6 |
| 600 mg Venetoclax | 5 |
| 900 mg Venetoclax | 3 |
| 1200 mg Venetoclax | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 300 mg Venetoclax | 13.0 | 8.31 | Not reported | Not reported | Not reported |
| 600 mg Venetoclax | 38.2 | 25.1 | Not reported | Not reported | Not reported |
| 900 mg Venetoclax | 26.3 | 20.1 | Not reported | Not reported | Not reported |
| 1200 mg Venetoclax | 71.5 | 35.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8.31
- value
- 13.0
- group Id
- OG001
- spread
- 25.1
- value
- 38.2
- group Id
- OG002
- spread
- 20.1
- value
- 26.3
- group Id
- OG003
- spread
- 35.8
- value
- 71.5
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 9
- units
- Participants
- description
- AUC is a measure of how long and how much drug is present in the body after dosing.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants who received a 300 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
- id
- OG000
- title
- 300 mg Venetoclax
- description
- Participants who received a 600 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
- id
- OG001
- title
- 600 mg Venetoclax
- description
- Participants who received a 900 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
- id
- OG002
- title
- 900 mg Venetoclax
- description
- Participants who received a 1200 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
- id
- OG003
- title
- 1200 mg Venetoclax
- param Type
- MEAN
- population Description
- Phase 1 dose escalation and safety expansion participants with available data
- reporting Status
- POSTED
- time Frame
- Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose (dose escalation cohort); (1200 mg dose): Cycle 2, Day 1 at predose (safety expansion cohort, 1200 mg dose)
- title
- Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to 24 Hours (AUC0-24) of Venetoclax
- type
- PRIMARY
- unit Of Measure
- µg•h/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice