TriangleNCT01871805 · OUTCOME
Area Under the Plasma Concentration (AUC) Versus Time Curve Extrapolated to Infinity (AUCinf) After Single Dose of Alectinib: Phase I
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- hour*ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3 (1 cycle = 21 days)
What was measured
AUCinf = AUC from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0- t) plus AUC (t-inf).
Analysis population: Phase I PK evaluable population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
Groups in this outcome
Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I
Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 240 mg Once and 300 mg BID (Fed): Phase I
Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 300 mg (Fasted): Phase I
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 460 mg (Fed): Phase I
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 600 mg (Fed): Phase I (20/40 mg)
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 600 mg (Fed): Phase I (150 mg)
Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 760 mg (Fed): Phase I
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 900 mg (Fed): Phase I (20/40 mg)
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 900 mg (Fed): Phase I (150 mg)
Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
| Group | Source count |
|---|---|
| Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I | 3 |
| Alectinib 240 mg Once and 300 mg BID (Fed): Phase I | 1 |
| Alectinib 300 mg (Fasted): Phase I | 3 |
| Alectinib 460 mg (Fed): Phase I | 7 |
| Alectinib 600 mg (Fed): Phase I (20/40 mg) | 6 |
| Alectinib 600 mg (Fed): Phase I (150 mg) | 6 |
| Alectinib 760 mg (Fed): Phase I | 7 |
| Alectinib 900 mg (Fed): Phase I (20/40 mg) | 7 |
| Alectinib 900 mg (Fed): Phase I (150 mg) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I | 1360 | 436 | Not reported | Not reported | Not reported |
| Alectinib 240 mg Once and 300 mg BID (Fed): Phase I | 858 | Not reported | Not reported | Not reported | Not reported |
| Alectinib 300 mg (Fasted): Phase I | 1030 | 481 | Not reported | Not reported | Not reported |
| Alectinib 460 mg (Fed): Phase I | 3280 | 2240 | Not reported | Not reported | Not reported |
| Alectinib 600 mg (Fed): Phase I (20/40 mg) | 3310 | 1110 | Not reported | Not reported | Not reported |
| Alectinib 600 mg (Fed): Phase I (150 mg) | 3190 | 1510 | Not reported | Not reported | Not reported |
| Alectinib 760 mg (Fed): Phase I | 4090 | 1680 | Not reported | Not reported | Not reported |
| Alectinib 900 mg (Fed): Phase I (20/40 mg) | 3730 | 2310 | Not reported | Not reported | Not reported |
| Alectinib 900 mg (Fed): Phase I (150 mg) | 7790 | 6210 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 436
- value
- 1360
- group Id
- OG001
- value
- 858
- group Id
- OG002
- spread
- 481
- value
- 1030
- group Id
- OG003
- spread
- 2240
- value
- 3280
- group Id
- OG004
- spread
- 1110
- value
- 3310
- group Id
- OG005
- spread
- 1510
- value
- 3190
- group Id
- OG006
- spread
- 1680
- value
- 4090
- group Id
- OG007
- spread
- 2310
- value
- 3730
- group Id
- OG008
- spread
- 6210
- value
- 7790
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 6
- units
- Participants
- description
- AUCinf = AUC from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0- t) plus AUC (t-inf).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG000
- title
- Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I
- description
- Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG001
- title
- Alectinib 240 mg Once and 300 mg BID (Fed): Phase I
- description
- Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG002
- title
- Alectinib 300 mg (Fasted): Phase I
- description
- Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG003
- title
- Alectinib 460 mg (Fed): Phase I
- description
- Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG004
- title
- Alectinib 600 mg (Fed): Phase I (20/40 mg)
- description
- Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG005
- title
- Alectinib 600 mg (Fed): Phase I (150 mg)
- description
- Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG006
- title
- Alectinib 760 mg (Fed): Phase I
- description
- Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG007
- title
- Alectinib 900 mg (Fed): Phase I (20/40 mg)
- description
- Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG008
- title
- Alectinib 900 mg (Fed): Phase I (150 mg)
- param Type
- MEAN
- population Description
- Phase I PK evaluable population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3 (1 cycle = 21 days)
- title
- Area Under the Plasma Concentration (AUC) Versus Time Curve Extrapolated to Infinity (AUCinf) After Single Dose of Alectinib: Phase I
- type
- SECONDARY
- unit Of Measure
- hour*ng/mL
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Preserved source evidence · Not medical advice