NCT02414139 · OUTCOME
Elimination Half-life (T1/2) of CMN288
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- hour
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
What was measured
T1/2 of CMN288 (metabolite of capmatinib) was estimated by non-compartmental analysis. T1/2 is the time it takes for the concentration of CMN288 in the bloodstream to decrease by half. Plasma concentrations of metabolite CMN288 were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL. Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
Analysis population: Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received at least one dose of capmatinib with extensive PK sampling collection and an evaluable PK parameter (T1/2 for CMN288) at the specified time points. Participants received capmatinib under the same administration conditions (fasted state) and were pooled together for analysis
Groups in this outcome
Cohorts 1-5: Capmatinib Administration in Fasted State
Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state
| Group | Source count |
|---|---|
| Cohorts 1-5: Capmatinib Administration in Fasted State | 40 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Cohorts 1-5: Capmatinib Administration in Fasted State | 40 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohorts 1-5: Capmatinib Administration in Fasted State | 3.14 | 1.42 | Not reported | Not reported | Not reported |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| Cohorts 1-5: Capmatinib Administration in Fasted State | 34 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohorts 1-5: Capmatinib Administration in Fasted State | 3.06 | 0.949 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.42
- value
- 3.14
- denoms
- counts
- group Id
- OG000
- value
- 40
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.949
- value
- 3.06
- denoms
- counts
- group Id
- OG000
- value
- 34
- units
- Participants
- title
- Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 40
- units
- Participants
- description
- T1/2 of CMN288 (metabolite of capmatinib) was estimated by non-compartmental analysis. T1/2 is the time it takes for the concentration of CMN288 in the bloodstream to decrease by half. Plasma concentrations of metabolite CMN288 were measured using validated LCMS/MS methods with a LLOQ of approximately 1.0 ng/mL. Only a subset of participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b, who had an extensive PK collection schedule, were included in this analysis
- dispersion Type
- Standard Deviation
- groups
- description
- Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received capmatinib in fasted state
- id
- OG000
- title
- Cohorts 1-5: Capmatinib Administration in Fasted State
- param Type
- MEAN
- population Description
- Participants from Cohorts 1a, 1b, 2, 3, 4, 5a and 5b who received at least one dose of capmatinib with extensive PK sampling collection and an evaluable PK parameter (T1/2 for CMN288) at the specified time points. Participants received capmatinib under the same administration conditions (fasted state) and were pooled together for analysis
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 and Day 15 at pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose. Each Cycle is 21 days
- title
- Elimination Half-life (T1/2) of CMN288
- type
- SECONDARY
- unit Of Measure
- hour
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Preserved source evidence · Not medical advice
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