TriangleNCT01390818 · OUTCOME
Apparent Volume of Distribution of Total SAR245409 During the Terminal Phase Following Oral Administration (Vz/f)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- litre
- 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
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.
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 | 174.8 | Not reported | 71.24 | 429.0 | Not reported |
| SAR245409 50mg | 223.4 | Not reported | 116.2 | 429.6 | Not reported |
| SAR245409 70mg | 238.5 | Not reported | 179.0 | 317.8 | 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 | 658.0 | Not reported | 211.9 | 2044 | Not reported |
| TNBC: SAR245409 70mg Once Daily | 175.2 | Not reported | 123.9 | 247.9 | Not reported |
| NSCLC: SAR245409 70mg Once Daily | 251.4 | Not reported | 158.4 | 398.9 | Not reported |
| CRC: SAR245409 70mg Once Daily | 353.6 | Not reported | 177.1 | 705.8 | Not reported |
| MEL: SAR245409 70mg Once Daily | 270.3 | Not reported | 175.6 | 416.0 | Not reported |
Day 15 (n=6, 8, 25, 1, 1, 2, 17, 17, 10, 13 )
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SAR245409 30mg | 165.7 | Not reported | 99.48 | 276.1 | Not reported |
| SAR245409 50mg | 257.2 | Not reported | 156.7 | 422.1 | Not reported |
| SAR245409 70mg | 355.9 | Not reported | 212.5 | 596.2 | 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 | 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. |
| TNBC: SAR245409 70mg Once Daily | 132.8 | Not reported | 96.16 | 183.4 | Not reported |
| NSCLC: SAR245409 70mg Once Daily | 247.1 | Not reported | 149.4 | 410.7 | Not reported |
| CRC: SAR245409 70mg Once Daily | 475.9 | Not reported | 128.0 | 1769 | Not reported |
| MEL: SAR245409 70mg Once Daily | 293.4 | Not reported | 141.6 | 607.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 71.24
- upper Limit
- 429.0
- value
- 174.8
- group Id
- OG001
- lower Limit
- 116.2
- upper Limit
- 429.6
- value
- 223.4
- group Id
- OG002
- lower Limit
- 179.0
- upper Limit
- 317.8
- value
- 238.5
- 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
- 211.9
- upper Limit
- 2044
- value
- 658.0
- group Id
- OG006
- lower Limit
- 123.9
- upper Limit
- 247.9
- value
- 175.2
- group Id
- OG007
- lower Limit
- 158.4
- upper Limit
- 398.9
- value
- 251.4
- group Id
- OG008
- lower Limit
- 177.1
- upper Limit
- 705.8
- value
- 353.6
- group Id
- OG009
- lower Limit
- 175.6
- upper Limit
- 416.0
- value
- 270.3
- title
- Day 1 (n=5, 9, 31, 2, 1, 3, 20, 17, 12, 12)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 99.48
- upper Limit
- 276.1
- value
- 165.7
- group Id
- OG001
- lower Limit
- 156.7
- upper Limit
- 422.1
- value
- 257.2
- group Id
- OG002
- lower Limit
- 212.5
- upper Limit
- 596.2
- value
- 355.9
- 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
- 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
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG006
- lower Limit
- 96.16
- upper Limit
- 183.4
- value
- 132.8
- group Id
- OG007
- lower Limit
- 149.4
- upper Limit
- 410.7
- value
- 247.1
- group Id
- OG008
- lower Limit
- 128.0
- upper Limit
- 1769
- value
- 475.9
- group Id
- OG009
- lower Limit
- 141.6
- upper Limit
- 607.7
- value
- 293.4
- title
- Day 15 (n=6, 8, 25, 1, 1, 2, 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
- Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.
- 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
- Apparent Volume of Distribution of Total SAR245409 During the Terminal Phase Following Oral Administration (Vz/f)
- type
- SECONDARY
- unit Of Measure
- litre
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Preserved source evidence · Not medical advice