TriangleNCT03894618 · OUTCOME
Volume of Distribution
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- liters per kg
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
What was measured
Volume of distribution of SL-279252
Analysis population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis.
Groups in this outcome
SL-279252 (0.0001 mg/kg S1)
0.0001 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.001 mg/kg S1)
0.001 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.003 mg/kg S1)
0.003 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.01 mg/kg S1)
0.01 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.03 mg/kg S1)
0.03 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.1 mg/kg S1)
0.1 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (0.3 mg/kg S1 or S2)
0.3 mg/kg of IV SL-279252 (Schedule 1 or Schedule 2)
SL-279252 (1.0 mg/kg S1 or S2)
1.0 mg/kg of IV SL-279252 (Schedule 1 or Schedule 2)
SL-279252 (3.0 mg/kg S1 or S2)
3.0 mg/kg of IV SL-279252 (Schedule 1 or Schedule 2)
SL-279252 (6.0 mg/kg S1)
6.0 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (12.0 mg/kg S1)
12.0 mg/kg of IV SL-279252 (Schedule 1)
SL-279252 (24.0 mg/kg S1)
24.0 mg/kg of IV SL-279252 (Schedule 1)
| Group | Source count |
|---|---|
| SL-279252 (0.0001 mg/kg S1) | 1 |
| SL-279252 (0.001 mg/kg S1) | 1 |
| SL-279252 (0.003 mg/kg S1) | 2 |
| SL-279252 (0.01 mg/kg S1) | 1 |
| SL-279252 (0.03 mg/kg S1) | 2 |
| SL-279252 (0.1 mg/kg S1) | 3 |
| SL-279252 (0.3 mg/kg S1 or S2) | 8 |
| SL-279252 (1.0 mg/kg S1 or S2) | 12 |
| SL-279252 (3.0 mg/kg S1 or S2) | 9 |
| SL-279252 (6.0 mg/kg S1) | 4 |
| SL-279252 (12.0 mg/kg S1) | 4 |
| SL-279252 (24.0 mg/kg S1) | 2 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| SL-279252 (0.0001 mg/kg S1) | 1 |
| SL-279252 (0.001 mg/kg S1) | 1 |
| SL-279252 (0.003 mg/kg S1) | 2 |
| SL-279252 (0.01 mg/kg S1) | 1 |
| SL-279252 (0.03 mg/kg S1) | 2 |
| SL-279252 (0.1 mg/kg S1) | 3 |
| SL-279252 (0.3 mg/kg S1 or S2) | 8 |
| SL-279252 (1.0 mg/kg S1 or S2) | 12 |
| SL-279252 (3.0 mg/kg S1 or S2) | 9 |
| SL-279252 (6.0 mg/kg S1) | 4 |
| SL-279252 (12.0 mg/kg S1) | 4 |
| SL-279252 (24.0 mg/kg S1) | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SL-279252 (0.0001 mg/kg S1) | NA | NA | Not reported | Not reported | Not estimable based on subjects' concentration profiles, including values below the limit of quantification |
| SL-279252 (0.001 mg/kg S1) | NA | NA | Not reported | Not reported | Not estimable based on subjects' concentration profiles, including values below the limit of quantification |
| SL-279252 (0.003 mg/kg S1) | 0.291 | 6.92 | Not reported | Not reported | Not reported |
| SL-279252 (0.01 mg/kg S1) | NA | NA | Not reported | Not reported | Not estimable based on subjects' concentration profiles, including values below the limit of quantification |
| SL-279252 (0.03 mg/kg S1) | 0.0664 | NA | Not reported | Not reported | Geometric Coefficient of Variation not calculable for a single participant (one participant's concentrations were below limit of quantitation) |
| SL-279252 (0.1 mg/kg S1) | 0.576 | 144 | Not reported | Not reported | Not reported |
| SL-279252 (0.3 mg/kg S1 or S2) | 0.894 | 38.0 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | 0.797 | 31.8 | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1 or S2) | 0.939 | 52.8 | Not reported | Not reported | Not reported |
| SL-279252 (6.0 mg/kg S1) | 0.562 | 33.8 | Not reported | Not reported | Not reported |
| SL-279252 (12.0 mg/kg S1) | 0.281 | 64.8 | Not reported | Not reported | Not reported |
| SL-279252 (24.0 mg/kg S1) | 0.348 | 17.4 | Not reported | Not reported | Not reported |
Cycle 2 Day 1 (Schedule 1 only)
| Group | Source count |
|---|---|
| SL-279252 (0.0001 mg/kg S1) | 1 |
| SL-279252 (0.001 mg/kg S1) | 1 |
| SL-279252 (0.003 mg/kg S1) | 2 |
| SL-279252 (0.01 mg/kg S1) | 0 |
| SL-279252 (0.03 mg/kg S1) | 2 |
| SL-279252 (0.1 mg/kg S1) | 3 |
| SL-279252 (0.3 mg/kg S1 or S2) | 4 |
| SL-279252 (1.0 mg/kg S1 or S2) | 5 |
| SL-279252 (3.0 mg/kg S1 or S2) | 5 |
| SL-279252 (6.0 mg/kg S1) | 2 |
| SL-279252 (12.0 mg/kg S1) | 4 |
| SL-279252 (24.0 mg/kg S1) | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SL-279252 (0.0001 mg/kg S1) | NA | NA | Not reported | Not reported | Not estimable based on subjects' concentration profiles, including values below the limit of quantification |
| SL-279252 (0.001 mg/kg S1) | NA | NA | Not reported | Not reported | Not estimable based on subjects' concentration profiles, including values below the limit of quantification |
| SL-279252 (0.003 mg/kg S1) | NA | NA | Not reported | Not reported | Not estimable based on subjects' concentration profiles, including values below the limit of quantification |
| SL-279252 (0.03 mg/kg S1) | NA | NA | Not reported | Not reported | Not estimable based on subjects' concentration profiles, including values below the limit of quantification |
| SL-279252 (0.1 mg/kg S1) | 0.200 | 46.3 | Not reported | Not reported | Not reported |
| SL-279252 (0.3 mg/kg S1 or S2) | 0.207 | 37.1 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | 0.237 | 23.7 | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1 or S2) | 0.229 | 12.5 | Not reported | Not reported | Not reported |
| SL-279252 (6.0 mg/kg S1) | 0.118 | 9.5 | Not reported | Not reported | Not reported |
| SL-279252 (12.0 mg/kg S1) | 0.0730 | 20.5 | Not reported | Not reported | Not reported |
| SL-279252 (24.0 mg/kg S1) | 0.0834 | 32.3 | Not reported | Not reported | Not reported |
Cycle 2 Day 1 (Schedule 2 only)
| Group | Source count |
|---|---|
| SL-279252 (0.0001 mg/kg S1) | 0 |
| SL-279252 (0.001 mg/kg S1) | 0 |
| SL-279252 (0.003 mg/kg S1) | 0 |
| SL-279252 (0.01 mg/kg S1) | 0 |
| SL-279252 (0.03 mg/kg S1) | 0 |
| SL-279252 (0.1 mg/kg S1) | 0 |
| SL-279252 (0.3 mg/kg S1 or S2) | 3 |
| SL-279252 (1.0 mg/kg S1 or S2) | 6 |
| SL-279252 (3.0 mg/kg S1 or S2) | 3 |
| SL-279252 (6.0 mg/kg S1) | 0 |
| SL-279252 (12.0 mg/kg S1) | 0 |
| SL-279252 (24.0 mg/kg S1) | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SL-279252 (0.3 mg/kg S1 or S2) | 0.178 | 8.63 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | 0.189 | 30.4 | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1 or S2) | 0.149 | 47.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable based on subjects' concentration profiles, including values below the limit of quantification
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Not estimable based on subjects' concentration profiles, including values below the limit of quantification
- group Id
- OG001
- spread
- NA
- value
- NA
- group Id
- OG002
- spread
- 6.92
- value
- 0.291
- comment
- Not estimable based on subjects' concentration profiles, including values below the limit of quantification
- group Id
- OG003
- spread
- NA
- value
- NA
- comment
- Geometric Coefficient of Variation not calculable for a single participant (one participant's concentrations were below limit of quantitation)
- group Id
- OG004
- spread
- NA
- value
- 0.0664
- group Id
- OG005
- spread
- 144
- value
- 0.576
- group Id
- OG006
- spread
- 38.0
- value
- 0.894
- group Id
- OG007
- spread
- 31.8
- value
- 0.797
- group Id
- OG008
- spread
- 52.8
- value
- 0.939
- group Id
- OG009
- spread
- 33.8
- value
- 0.562
- group Id
- OG010
- spread
- 64.8
- value
- 0.281
- group Id
- OG011
- spread
- 17.4
- value
- 0.348
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- comment
- Not estimable based on subjects' concentration profiles, including values below the limit of quantification
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Not estimable based on subjects' concentration profiles, including values below the limit of quantification
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Not estimable based on subjects' concentration profiles, including values below the limit of quantification
- group Id
- OG002
- spread
- NA
- value
- NA
- comment
- Not estimable based on subjects' concentration profiles, including values below the limit of quantification
- group Id
- OG004
- spread
- NA
- value
- NA
- group Id
- OG005
- spread
- 46.3
- value
- 0.200
- group Id
- OG006
- spread
- 37.1
- value
- 0.207
- group Id
- OG007
- spread
- 23.7
- value
- 0.237
- group Id
- OG008
- spread
- 12.5
- value
- 0.229
- group Id
- OG009
- spread
- 9.5
- value
- 0.118
- group Id
- OG010
- spread
- 20.5
- value
- 0.0730
- group Id
- OG011
- spread
- 32.3
- value
- 0.0834
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 2
- units
- Participants
- title
- Cycle 2 Day 1 (Schedule 1 only)
- categories
- measurements
- group Id
- OG006
- spread
- 8.63
- value
- 0.178
- group Id
- OG007
- spread
- 30.4
- value
- 0.189
- group Id
- OG008
- spread
- 47.1
- value
- 0.149
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Cycle 2 Day 1 (Schedule 2 only)
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 2
- units
- Participants
- description
- Volume of distribution of SL-279252
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- 0.0001 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG000
- title
- SL-279252 (0.0001 mg/kg S1)
- description
- 0.001 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG001
- title
- SL-279252 (0.001 mg/kg S1)
- description
- 0.003 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG002
- title
- SL-279252 (0.003 mg/kg S1)
- description
- 0.01 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG003
- title
- SL-279252 (0.01 mg/kg S1)
- description
- 0.03 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG004
- title
- SL-279252 (0.03 mg/kg S1)
- description
- 0.1 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG005
- title
- SL-279252 (0.1 mg/kg S1)
- description
- 0.3 mg/kg of IV SL-279252 (Schedule 1 or Schedule 2)
- id
- OG006
- title
- SL-279252 (0.3 mg/kg S1 or S2)
- description
- 1.0 mg/kg of IV SL-279252 (Schedule 1 or Schedule 2)
- id
- OG007
- title
- SL-279252 (1.0 mg/kg S1 or S2)
- description
- 3.0 mg/kg of IV SL-279252 (Schedule 1 or Schedule 2)
- id
- OG008
- title
- SL-279252 (3.0 mg/kg S1 or S2)
- description
- 6.0 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG009
- title
- SL-279252 (6.0 mg/kg S1)
- description
- 12.0 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG010
- title
- SL-279252 (12.0 mg/kg S1)
- description
- 24.0 mg/kg of IV SL-279252 (Schedule 1)
- id
- OG011
- title
- SL-279252 (24.0 mg/kg S1)
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
- title
- Volume of Distribution
- type
- SECONDARY
- unit Of Measure
- liters per kg
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Preserved source evidence · Not medical advice