TriangleNCT04238819 · OUTCOME
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC0-tlast) of Abemaciclib in Part A
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanogram *hour per milliliter (ng*h/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose, 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
What was measured
PK: (AUC0-tlast) was reported.
Analysis population: All participants in Part A who received at least one dose of abemaciclib and had evaluable PK data. Per planned analysis, PK analysis was performed as per the dose of study drug received.
Groups in this outcome
Part A: 70 mg/m² Abemaciclib
All part A participants who received 70 mg/m² abemaciclib were included under this arm.
Part A: 55 mg/m² Abemaciclib
All part A participants who received 55 mg/m² abemaciclib were included under this arm.
| Group | Source count |
|---|---|
| Part A: 70 mg/m² Abemaciclib | 6 |
| Part A: 55 mg/m² Abemaciclib | 13 |
Reported measurements
Cycle 1, Day 1
| Group | Source count |
|---|---|
| Part A: 70 mg/m² Abemaciclib | 6 |
| Part A: 55 mg/m² Abemaciclib | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: 70 mg/m² Abemaciclib | 730 | 33 | Not reported | Not reported | Not reported |
| Part A: 55 mg/m² Abemaciclib | 534 | 116 | Not reported | Not reported | Not reported |
Cycle 2, Day 1
| Group | Source count |
|---|---|
| Part A: 70 mg/m² Abemaciclib | 2 |
| Part A: 55 mg/m² Abemaciclib | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: 70 mg/m² Abemaciclib | NA | NA | Not reported | Not reported | Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there were only two participants. Individual values reported: 373.72 ng\*h/mL and 3373.97 ng\*h/mL. |
| Part A: 55 mg/m² Abemaciclib | 757 | 100 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 33
- value
- 730
- group Id
- OG001
- spread
- 116
- value
- 534
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- Cycle 1, Day 1
- categories
- measurements
- comment
- Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there were only two participants. Individual values reported: 373.72 ng\*h/mL and 3373.97 ng\*h/mL.
- group Id
- OG000
- spread
- NA
- value
- NA
- group Id
- OG001
- spread
- 100
- value
- 757
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Cycle 2, Day 1
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- PK: (AUC0-tlast) was reported.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- All part A participants who received 70 mg/m² abemaciclib were included under this arm.
- id
- OG000
- title
- Part A: 70 mg/m² Abemaciclib
- description
- All part A participants who received 55 mg/m² abemaciclib were included under this arm.
- id
- OG001
- title
- Part A: 55 mg/m² Abemaciclib
- param Type
- GEOMETRIC_MEAN
- population Description
- All participants in Part A who received at least one dose of abemaciclib and had evaluable PK data. Per planned analysis, PK analysis was performed as per the dose of study drug received.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
- title
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC0-tlast) of Abemaciclib in Part A
- type
- PRIMARY
- unit Of Measure
- nanogram *hour per milliliter (ng*h/mL)
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Preserved source evidence · Not medical advice