TriangleNCT03894618 · OUTCOME
Area Under the Serum Concentration-time Curve (AUC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hours*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 AUC is the area under the serum concentration time curve following single and multiple doses of SL-279252. AUC (0-inf; from time 0 to infinity) is reported for C1D1 and C2D1 (Schedule 1 only); AUC (tau; over a dosing interval) is reported for C1D15 and C2D1 (Schedule 2 only).
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) | 56.6 | 77.5 | 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) | 804 | 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) | 2960 | 40.1 | Not reported | Not reported | Not reported |
| SL-279252 (0.3 mg/kg S1 or S2) | 10900 | 39.2 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | 38800 | 32.7 | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1 or S2) | 110000 | 52.9 | Not reported | Not reported | Not reported |
| SL-279252 (6.0 mg/kg S1) | 353000 | 29.4 | Not reported | Not reported | Not reported |
| SL-279252 (12.0 mg/kg S1) | 1140000 | 48.2 | Not reported | Not reported | Not reported |
| SL-279252 (24.0 mg/kg S1) | 1380000 | 22.4 | 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) | 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) | 68.8 | 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) | 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) | 3410 | 47.4 | Not reported | Not reported | Not reported |
| SL-279252 (0.3 mg/kg S1 or S2) | 11600 | 43.5 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | 40800 | 38.9 | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1 or S2) | 130000 | 40.5 | Not reported | Not reported | Not reported |
| SL-279252 (6.0 mg/kg S1) | 325000 | 31.5 | Not reported | Not reported | Not reported |
| SL-279252 (12.0 mg/kg S1) | 1100000 | 21.2 | Not reported | Not reported | Not reported |
| SL-279252 (24.0 mg/kg S1) | 1390000 | 16.9 | 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) | 3240 | 35.7 | Not reported | Not reported | Not reported |
| SL-279252 (0.3 mg/kg S1 or S2) | 10800 | 43.7 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | 36800 | 24.1 | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1 or S2) | 103000 | 15.3 | Not reported | Not reported | Not reported |
| SL-279252 (6.0 mg/kg S1) | 388000 | 28.2 | Not reported | Not reported | Not reported |
| SL-279252 (12.0 mg/kg S1) | 1160000 | 29.7 | Not reported | Not reported | Not reported |
| SL-279252 (24.0 mg/kg S1) | 1560000 | 15.0 | 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) | 11500 | 16.1 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | 33600 | 58.5 | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1 or S2) | 145000 | 35.2 | 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
- 77.5
- value
- 56.6
- 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
- 804
- group Id
- OG005
- spread
- 40.1
- value
- 2960
- group Id
- OG006
- spread
- 39.2
- value
- 10900
- group Id
- OG007
- spread
- 32.7
- value
- 38800
- group Id
- OG008
- spread
- 52.9
- value
- 110000
- group Id
- OG009
- spread
- 29.4
- value
- 353000
- group Id
- OG010
- spread
- 48.2
- value
- 1140000
- group Id
- OG011
- spread
- 22.4
- value
- 1380000
- 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
- Geometric Coefficient of Variation not calculable for a single participant
- group Id
- OG002
- spread
- NA
- value
- 68.8
- comment
- Not estimable based on subjects' concentration profiles, including values below the limit of quantification
- group Id
- OG003
- 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
- 47.4
- value
- 3410
- group Id
- OG006
- spread
- 43.5
- value
- 11600
- group Id
- OG007
- spread
- 38.9
- value
- 40800
- group Id
- OG008
- spread
- 40.5
- value
- 130000
- group Id
- OG009
- spread
- 31.5
- value
- 325000
- group Id
- OG010
- spread
- 21.2
- value
- 1100000
- group Id
- OG011
- spread
- 16.9
- value
- 1390000
- 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
- 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
- 35.7
- value
- 3240
- group Id
- OG006
- spread
- 43.7
- value
- 10800
- group Id
- OG007
- spread
- 24.1
- value
- 36800
- group Id
- OG008
- spread
- 15.3
- value
- 103000
- group Id
- OG009
- spread
- 28.2
- value
- 388000
- group Id
- OG010
- spread
- 29.7
- value
- 1160000
- group Id
- OG011
- spread
- 15.0
- value
- 1560000
- 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
- 16.1
- value
- 11500
- group Id
- OG007
- spread
- 58.5
- value
- 33600
- group Id
- OG008
- spread
- 35.2
- value
- 145000
- 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 AUC is the area under the serum concentration time curve following single and multiple doses of SL-279252. AUC (0-inf; from time 0 to infinity) is reported for C1D1 and C2D1 (Schedule 1 only); AUC (tau; over a dosing interval) is reported for C1D15 and C2D1 (Schedule 2 only).
- 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
- Area Under the Serum Concentration-time Curve (AUC)
- type
- SECONDARY
- unit Of Measure
- hours*ng/mL
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Preserved source evidence · Not medical advice