TriangleNCT01390818 · OUTCOME
Total Body Clearance (CL/f) of SAR245409
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- litre per hour
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
What was measured
The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the dose with area under the plasma concentration time curve from time zero to infinity (AUC 0-inf)=Dose/AUC 0-inf.
Analysis population: The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Groups in this outcome
SAR245409 30mg
SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
SAR245409 50mg
SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
SAR245409 70mg
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
SAR245409 90mg
SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
SAR245409 30mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
SAR245409 50mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
TNBC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
NSCLC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
CRC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
MEL: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
| Group | Source count |
|---|---|
| SAR245409 30mg | 6 |
| SAR245409 50mg | 11 |
| SAR245409 70mg | 36 |
| SAR245409 90mg | 2 |
| SAR245409 30mg Twice Daily | 1 |
| SAR245409 50mg Twice Daily | 4 |
| TNBC: SAR245409 70mg Once Daily | 26 |
| NSCLC: SAR245409 70mg Once Daily | 24 |
| CRC: SAR245409 70mg Once Daily | 18 |
| MEL: SAR245409 70mg Once Daily | 15 |
Reported measurements
Day 1 (n=5, 9, 31, 2, 1, 3, 20, 17, 12, 12)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SAR245409 30mg | 41.80 | Not reported | 10.62 | 164.5 | Not reported |
| SAR245409 50mg | 42.93 | Not reported | 23.89 | 77.16 | Not reported |
| SAR245409 70mg | 46.54 | Not reported | 34.42 | 62.94 | Not reported |
| SAR245409 90mg | NA | Not reported | NA | NA | Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation. |
| SAR245409 30mg Twice Daily | NA | Not reported | NA | NA | Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation. |
| SAR245409 50mg Twice Daily | 151.4 | Not reported | 69.37 | 330.4 | Not reported |
| TNBC: SAR245409 70mg Once Daily | 35.43 | Not reported | 25.26 | 49.69 | Not reported |
| NSCLC: SAR245409 70mg Once Daily | 48.40 | Not reported | 34.12 | 68.64 | Not reported |
| CRC: SAR245409 70mg Once Daily | 55.51 | Not reported | 25.52 | 120.7 | Not reported |
| MEL: SAR245409 70mg Once Daily | 61.29 | Not reported | 40.26 | 93.30 | Not reported |
Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SAR245409 30mg | 33.78 | Not reported | 15.16 | 75.26 | Not reported |
| SAR245409 50mg | 42.81 | Not reported | 22.39 | 81.85 | Not reported |
| SAR245409 70mg | 51.38 | Not reported | 34.68 | 76.13 | Not reported |
| SAR245409 90mg | NA | Not reported | NA | NA | Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation. |
| SAR245409 30mg Twice Daily | NA | Not reported | NA | NA | Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation. |
| SAR245409 50mg Twice Daily | 92.90 | Not reported | 9.667 | 892.8 | Not reported |
| TNBC: SAR245409 70mg Once Daily | 29.28 | Not reported | 20.78 | 41.26 | Not reported |
| NSCLC: SAR245409 70mg Once Daily | 48.69 | Not reported | 31.25 | 75.88 | Not reported |
| CRC: SAR245409 70mg Once Daily | 51.24 | Not reported | 20.38 | 128.8 | Not reported |
| MEL: SAR245409 70mg Once Daily | 65.16 | Not reported | 38.64 | 109.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.62
- upper Limit
- 164.5
- value
- 41.80
- group Id
- OG001
- lower Limit
- 23.89
- upper Limit
- 77.16
- value
- 42.93
- group Id
- OG002
- lower Limit
- 34.42
- upper Limit
- 62.94
- value
- 46.54
- comment
- Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG005
- lower Limit
- 69.37
- upper Limit
- 330.4
- value
- 151.4
- group Id
- OG006
- lower Limit
- 25.26
- upper Limit
- 49.69
- value
- 35.43
- group Id
- OG007
- lower Limit
- 34.12
- upper Limit
- 68.64
- value
- 48.40
- group Id
- OG008
- lower Limit
- 25.52
- upper Limit
- 120.7
- value
- 55.51
- group Id
- OG009
- lower Limit
- 40.26
- upper Limit
- 93.30
- value
- 61.29
- title
- Day 1 (n=5, 9, 31, 2, 1, 3, 20, 17, 12, 12)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.16
- upper Limit
- 75.26
- value
- 33.78
- group Id
- OG001
- lower Limit
- 22.39
- upper Limit
- 81.85
- value
- 42.81
- group Id
- OG002
- lower Limit
- 34.68
- upper Limit
- 76.13
- value
- 51.38
- comment
- Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG005
- lower Limit
- 9.667
- upper Limit
- 892.8
- value
- 92.90
- group Id
- OG006
- lower Limit
- 20.78
- upper Limit
- 41.26
- value
- 29.28
- group Id
- OG007
- lower Limit
- 31.25
- upper Limit
- 75.88
- value
- 48.69
- group Id
- OG008
- lower Limit
- 20.38
- upper Limit
- 128.8
- value
- 51.24
- group Id
- OG009
- lower Limit
- 38.64
- upper Limit
- 109.9
- value
- 65.16
- title
- Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 36
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 26
- group Id
- OG007
- value
- 24
- group Id
- OG008
- value
- 18
- group Id
- OG009
- value
- 15
- units
- Participants
- description
- The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the dose with area under the plasma concentration time curve from time zero to infinity (AUC 0-inf)=Dose/AUC 0-inf.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
- id
- OG000
- title
- SAR245409 30mg
- description
- SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
- id
- OG001
- title
- SAR245409 50mg
- description
- SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
- id
- OG002
- title
- SAR245409 70mg
- description
- SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
- id
- OG003
- title
- SAR245409 90mg
- description
- SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
- id
- OG004
- title
- SAR245409 30mg Twice Daily
- description
- SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
- id
- OG005
- title
- SAR245409 50mg Twice Daily
- description
- SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
- id
- OG006
- title
- TNBC: SAR245409 70mg Once Daily
- description
- SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
- id
- OG007
- title
- NSCLC: SAR245409 70mg Once Daily
- description
- SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
- id
- OG008
- title
- CRC: SAR245409 70mg Once Daily
- description
- SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
- id
- OG009
- title
- MEL: SAR245409 70mg Once Daily
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
- reporting Status
- POSTED
- time Frame
- Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
- title
- Total Body Clearance (CL/f) of SAR245409
- type
- SECONDARY
- unit Of Measure
- litre per hour
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Preserved source evidence · Not medical advice