TriangleNCT01871805 · OUTCOME
Cmax After Multiple 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
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1 (1 cycle = 21 days)
Analysis population: Phase I PK evaluable population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
Groups in this outcome
Alectinib 300 mg (Fasted): Phase I
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 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 300 mg (Fasted): Phase I | 6 |
| Alectinib 460 mg (Fed): Phase I | 7 |
| Alectinib 600 mg (Fed): Phase I (20/40 mg) | 5 |
| Alectinib 600 mg (Fed): Phase I (150 mg) | 6 |
| Alectinib 760 mg (Fed): Phase I | 5 |
| Alectinib 900 mg (Fed): Phase I (20/40 mg) | 7 |
| Alectinib 900 mg (Fed): Phase I (150 mg) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib 300 mg (Fasted): Phase I | 259 | 79.0 | Not reported | Not reported | Not reported |
| Alectinib 460 mg (Fed): Phase I | 618 | 165 | Not reported | Not reported | Not reported |
| Alectinib 600 mg (Fed): Phase I (20/40 mg) | 765 | 176 | Not reported | Not reported | Not reported |
| Alectinib 600 mg (Fed): Phase I (150 mg) | 670 | 360 | Not reported | Not reported | Not reported |
| Alectinib 760 mg (Fed): Phase I | 733 | 98.0 | Not reported | Not reported | Not reported |
| Alectinib 900 mg (Fed): Phase I (20/40 mg) | 1140 | 448 | Not reported | Not reported | Not reported |
| Alectinib 900 mg (Fed): Phase I (150 mg) | 1200 | 311 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 79.0
- value
- 259
- group Id
- OG001
- spread
- 165
- value
- 618
- group Id
- OG002
- spread
- 176
- value
- 765
- group Id
- OG003
- spread
- 360
- value
- 670
- group Id
- OG004
- spread
- 98.0
- value
- 733
- group Id
- OG005
- spread
- 448
- value
- 1140
- group Id
- OG006
- spread
- 311
- value
- 1200
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 4
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 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
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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
- OG005
- 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
- OG006
- 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 and 10 hours post-dose on Cycle 2 Day 1 (1 cycle = 21 days)
- title
- Cmax After Multiple Dose of Alectinib: Phase I
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice