TriangleNCT03894618 · OUTCOME
Minimum Serum Concentration (Cmin) 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 15 and Cycle 2 Day 1 (cycle = 28 days)
What was measured
The Cmin is the minimum 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 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) | 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) | 1 |
Reported measurements
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) | 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) | 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) | 1 |
| 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 (0.01 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) | NA | NA | Not reported | Not reported | Not estimable based on subjects' concentration profiles, including values below the limit of quantification |
| SL-279252 (0.3 mg/kg S1 or S2) | 1.03 | 71.9 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | 3.77 | 56.5 | Not reported | Not reported | Not reported |
| SL-279252 (3.0 mg/kg S1 or S2) | 10.4 | 124 | Not reported | Not reported | Not reported |
| SL-279252 (6.0 mg/kg S1) | 29.0 | 43.0 | Not reported | Not reported | Not reported |
| SL-279252 (12.0 mg/kg S1) | 90.7 | 100 | Not reported | Not reported | Not reported |
| SL-279252 (24.0 mg/kg S1) | 12.7 | NA | Not reported | Not reported | Geometric Coefficient of Variation not calculable for a single participant |
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) | 1.12 | 75.2 | Not reported | Not reported | Not reported |
| SL-279252 (1.0 mg/kg S1 or S2) | NA | NA | Not reported | Not reported | Not estimable based on subjects' concentration profiles, including values below the limit of quantification |
| SL-279252 (3.0 mg/kg S1 or S2) | 11.9 | 164 | 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
- 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
- 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
- comment
- Not estimable based on subjects' concentration profiles, including values below the limit of quantification
- group Id
- OG005
- spread
- NA
- value
- NA
- group Id
- OG006
- spread
- 71.9
- value
- 1.03
- group Id
- OG007
- spread
- 56.5
- value
- 3.77
- group Id
- OG008
- spread
- 124
- value
- 10.4
- group Id
- OG009
- spread
- 43.0
- value
- 29.0
- group Id
- OG010
- spread
- 100
- value
- 90.7
- comment
- Geometric Coefficient of Variation not calculable for a single participant
- group Id
- OG011
- spread
- NA
- value
- 12.7
- 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
- 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
- 1
- units
- Participants
- title
- Cycle 1 Day 15
- categories
- measurements
- group Id
- OG006
- spread
- 75.2
- value
- 1.12
- comment
- Not estimable based on subjects' concentration profiles, including values below the limit of quantification
- group Id
- OG007
- spread
- NA
- value
- NA
- group Id
- OG008
- spread
- 164
- value
- 11.9
- 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
- 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
- 1
- units
- Participants
- description
- The Cmin is the minimum 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 below the limit of quantitation or not available for analysis.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 15 and Cycle 2 Day 1 (cycle = 28 days)
- title
- Minimum Serum Concentration (Cmin) of SL-279252
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice