NCT02246621 · OUTCOME
PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- liters/hour (L/h)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose
What was measured
PK: Hepatic Clearance of Abemaciclib, and apparent hepatic clearance of its Metabolites M2 and M20
Analysis population: All randomized participants who received at least one dose of study drug with evaluable PK data.
Groups in this outcome
Abemaciclib + NSAI
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
| Group | Source count |
|---|---|
| Abemaciclib + NSAI | 322 |
Reported measurements
Abemaciclib
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + NSAI | 23.0 | 26.7 | Not reported | Not reported | Not reported |
M2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + NSAI | 21.6 | 50.4 | Not reported | Not reported | Not reported |
M20
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + NSAI | 26.0 | 46.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 26.7
- value
- 23.0
- title
- Abemaciclib
- categories
- measurements
- group Id
- OG000
- spread
- 50.4
- value
- 21.6
- title
- M2
- categories
- measurements
- group Id
- OG000
- spread
- 46.4
- value
- 26.0
- title
- M20
- denoms
- counts
- group Id
- OG000
- value
- 322
- units
- Participants
- description
- PK: Hepatic Clearance of Abemaciclib, and apparent hepatic clearance of its Metabolites M2 and M20
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- 150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
- id
- OG000
- title
- Abemaciclib + NSAI
- param Type
- GEOMETRIC_MEAN
- population Description
- All randomized participants who received at least one dose of study drug with evaluable PK data.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose
- title
- PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20
- type
- SECONDARY
- unit Of Measure
- liters/hour (L/h)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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