TriangleNCT03894618 · OUTCOME
Maximum Serum Concentration (Cmax) of SL-279252
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- 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
The Cmax is the maximum observed serum concentration of SL-279252 following single and multiple doses
Analysis population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were 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) | 3.75 | NA | Not reported | Not reported | Geometric Coefficient of Variation not calculable for a single participant |
| SL-279252 (0.003 mg/kg S1) | 30.8 | 4.60 | Not reported | Not reported | Not reported |
| SL-279252 (0.01 mg/kg S1) | 93.4 | NA | Not reported | Not reported | Geometric Coefficient of Variation not calculable for a single participant |
| SL-279252 (0.03 mg/kg S1) | 427 | 1.82 | Not reported | Not reported | Not reported |
| SL-279252 (0.1 mg/kg S1) | 734 | 42.9 | Not reported | Not reported | Not reported |
| SL-279252 (0.3 mg/kg S1 or S2) | 3580 | 29.6 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | 10200 | 42.0 | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1 or S2) | 28100 | 43.0 | Not reported | Not reported | Not reported |
| SL-279252 (6.0 mg/kg S1) | 83600 | 26.3 | Not reported | Not reported | Not reported |
| SL-279252 (12.0 mg/kg S1) | 248000 | 34.7 | Not reported | Not reported | Not reported |
| SL-279252 (24.0 mg/kg S1) | 320000 | 16.0 | Not reported | Not reported | Not reported |
Cycle 1 Day 15
| 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) | 1 |
| 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) | 7 |
| 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) | 3 |
| 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) | 3.22 | NA | Not reported | Not reported | Geometric Coefficient of Variation not calculable for a single participant |
| SL-279252 (0.003 mg/kg S1) | 19.5 | NA | Not reported | Not reported | Geometric Coefficient of Variation not calculable for a single participant |
| 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) | 360 | 6.09 | Not reported | Not reported | Not reported |
| SL-279252 (0.1 mg/kg S1) | 731 | 35.9 | Not reported | Not reported | Not reported |
| SL-279252 (0.3 mg/kg S1 or S2) | 2920 | 52.9 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | 10400 | 45.9 | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1 or S2) | 26100 | 67.0 | Not reported | Not reported | Not reported |
| SL-279252 (6.0 mg/kg S1) | 75300 | 21.5 | Not reported | Not reported | Not reported |
| SL-279252 (12.0 mg/kg S1) | 277000 | 10.5 | Not reported | Not reported | Not reported |
| SL-279252 (24.0 mg/kg S1) | 349000 | 4.05 | 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) | 50.6 | 49.2 | Not reported | Not reported | Not reported |
| SL-279252 (0.03 mg/kg S1) | 408 | 13.0 | Not reported | Not reported | Not reported |
| SL-279252 (0.1 mg/kg S1) | 1090 | 20.9 | Not reported | Not reported | Not reported |
| SL-279252 (0.3 mg/kg S1 or S2) | 4260 | 24.2 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | 9760 | 28.4 | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1 or S2) | 25400 | 103 | Not reported | Not reported | Not reported |
| SL-279252 (6.0 mg/kg S1) | 94100 | 15.6 | Not reported | Not reported | Not reported |
| SL-279252 (12.0 mg/kg S1) | 236000 | 25.8 | Not reported | Not reported | Not reported |
| SL-279252 (24.0 mg/kg S1) | 355000 | 7.97 | 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) | 4110 | 13.4 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | 11700 | 36.9 | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1 or S2) | 38300 | 22.7 | 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
- Geometric Coefficient of Variation not calculable for a single participant
- group Id
- OG001
- spread
- NA
- value
- 3.75
- group Id
- OG002
- spread
- 4.60
- value
- 30.8
- comment
- Geometric Coefficient of Variation not calculable for a single participant
- group Id
- OG003
- spread
- NA
- value
- 93.4
- group Id
- OG004
- spread
- 1.82
- value
- 427
- group Id
- OG005
- spread
- 42.9
- value
- 734
- group Id
- OG006
- spread
- 29.6
- value
- 3580
- group Id
- OG007
- spread
- 42.0
- value
- 10200
- group Id
- OG008
- spread
- 43.0
- value
- 28100
- group Id
- OG009
- spread
- 26.3
- value
- 83600
- group Id
- OG010
- spread
- 34.7
- value
- 248000
- group Id
- OG011
- spread
- 16.0
- value
- 320000
- 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
- Geometric Coefficient of Variation not calculable for a single participant
- group Id
- OG001
- spread
- NA
- value
- 3.22
- comment
- Geometric Coefficient of Variation not calculable for a single participant
- group Id
- OG002
- spread
- NA
- value
- 19.5
- comment
- Not estimable based on subjects' concentration profiles, including values below the limit of quantification
- group Id
- OG003
- spread
- NA
- value
- NA
- group Id
- OG004
- spread
- 6.09
- value
- 360
- group Id
- OG005
- spread
- 35.9
- value
- 731
- group Id
- OG006
- spread
- 52.9
- value
- 2920
- group Id
- OG007
- spread
- 45.9
- value
- 10400
- group Id
- OG008
- spread
- 67.0
- value
- 26100
- group Id
- OG009
- spread
- 21.5
- value
- 75300
- group Id
- OG010
- spread
- 10.5
- value
- 277000
- group Id
- OG011
- spread
- 4.05
- value
- 349000
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 15
- 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
- 49.2
- value
- 50.6
- group Id
- OG004
- spread
- 13.0
- value
- 408
- group Id
- OG005
- spread
- 20.9
- value
- 1090
- group Id
- OG006
- spread
- 24.2
- value
- 4260
- group Id
- OG007
- spread
- 28.4
- value
- 9760
- group Id
- OG008
- spread
- 103
- value
- 25400
- group Id
- OG009
- spread
- 15.6
- value
- 94100
- group Id
- OG010
- spread
- 25.8
- value
- 236000
- group Id
- OG011
- spread
- 7.97
- value
- 355000
- 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
- 13.4
- value
- 4110
- group Id
- OG007
- spread
- 36.9
- value
- 11700
- group Id
- OG008
- spread
- 22.7
- value
- 38300
- 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
- The Cmax is the maximum observed serum concentration of SL-279252 following single and multiple doses
- 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 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
- Maximum Serum Concentration (Cmax) of SL-279252
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice