TriangleNCT01177397 · OUTCOME
Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) for Metabolite M1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*h/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
What was measured
AUCt is defined as the area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration. Plasma metabolite M1 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 10.0 ng/mL.
Analysis population: All treated participants with available pharmacokinetic data in Part A.
Groups in this outcome
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
| Group | Source count |
|---|---|
| Part A: CC-223 7.5 mg | 1 |
| Part A: CC-223 15 mg | 2 |
| Part A: CC-223 30 mg | 8 |
| Part A: CC-223 45 mg | 9 |
| Part A: CC-223 60 mg | 7 |
Reported measurements
Day 1
| Group | Source count |
|---|---|
| Part A: CC-223 7.5 mg | 1 |
| Part A: CC-223 15 mg | 2 |
| Part A: CC-223 30 mg | 8 |
| Part A: CC-223 45 mg | 9 |
| Part A: CC-223 60 mg | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: CC-223 7.5 mg | 4583 | NA | Not reported | Not reported | Insufficient data values to calculate coefficient of variation. |
| Part A: CC-223 15 mg | 3788 | 121.2 | Not reported | Not reported | Not reported |
| Part A: CC-223 30 mg | 18964 | 45.1 | Not reported | Not reported | Not reported |
| Part A: CC-223 45 mg | 19938 | 30.1 | Not reported | Not reported | Not reported |
| Part A: CC-223 60 mg | 23702 | 98.1 | Not reported | Not reported | Not reported |
Day 15
| Group | Source count |
|---|---|
| Part A: CC-223 7.5 mg | 1 |
| Part A: CC-223 15 mg | 2 |
| Part A: CC-223 30 mg | 6 |
| Part A: CC-223 45 mg | 7 |
| Part A: CC-223 60 mg | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: CC-223 7.5 mg | 6401 | NA | Not reported | Not reported | Insufficient data values to calculate coefficient of variation. |
| Part A: CC-223 15 mg | 4388 | 133.8 | Not reported | Not reported | Not reported |
| Part A: CC-223 30 mg | 27389 | 48.5 | Not reported | Not reported | Not reported |
| Part A: CC-223 45 mg | 30823 | 38.3 | Not reported | Not reported | Not reported |
| Part A: CC-223 60 mg | 33070 | 101.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Insufficient data values to calculate coefficient of variation.
- group Id
- OG000
- spread
- NA
- value
- 4583
- group Id
- OG001
- spread
- 121.2
- value
- 3788
- group Id
- OG002
- spread
- 45.1
- value
- 18964
- group Id
- OG003
- spread
- 30.1
- value
- 19938
- group Id
- OG004
- spread
- 98.1
- value
- 23702
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 7
- units
- Participants
- title
- Day 1
- categories
- measurements
- comment
- Insufficient data values to calculate coefficient of variation.
- group Id
- OG000
- spread
- NA
- value
- 6401
- group Id
- OG001
- spread
- 133.8
- value
- 4388
- group Id
- OG002
- spread
- 48.5
- value
- 27389
- group Id
- OG003
- spread
- 38.3
- value
- 30823
- group Id
- OG004
- spread
- 101.6
- value
- 33070
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- Day 15
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 7
- units
- Participants
- description
- AUCt is defined as the area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration. Plasma metabolite M1 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 10.0 ng/mL.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG000
- title
- Part A: CC-223 7.5 mg
- description
- Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG001
- title
- Part A: CC-223 15 mg
- description
- Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG002
- title
- Part A: CC-223 30 mg
- description
- Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG003
- title
- Part A: CC-223 45 mg
- description
- Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG004
- title
- Part A: CC-223 60 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- All treated participants with available pharmacokinetic data in Part A.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
- title
- Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) for Metabolite M1
- type
- SECONDARY
- unit Of Measure
- ng*h/mL
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Preserved source evidence · Not medical advice