TriangleNCT01871805 · OUTCOME
Maximum Observed Plasma Concentration (Cmax) 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
- nanograms per milliliter (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)
Analysis population: Phase I pharmacokinetic (PK) evaluable population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. '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 | 73.5 | 12.4 | Not reported | Not reported | Not reported |
| Alectinib 240 mg Once and 300 mg BID (Fed): Phase I | 87.7 | Not reported | Not reported | Not reported | Not reported |
| Alectinib 300 mg (Fasted): Phase I | 45.3 | 9.24 | Not reported | Not reported | Not reported |
| Alectinib 460 mg (Fed): Phase I | 142.00 | 71.4 | Not reported | Not reported | Not reported |
| Alectinib 600 mg (Fed): Phase I (20/40 mg) | 158.0 | 67.2 | Not reported | Not reported | Not reported |
| Alectinib 600 mg (Fed): Phase I (150 mg) | 186.0 | 43.1 | Not reported | Not reported | Not reported |
| Alectinib 760 mg (Fed): Phase I | 257.0 | 83.1 | Not reported | Not reported | Not reported |
| Alectinib 900 mg (Fed): Phase I (20/40 mg) | 186.0 | 120.0 | Not reported | Not reported | Not reported |
| Alectinib 900 mg (Fed): Phase I (150 mg) | 295.0 | 131.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.4
- value
- 73.5
- group Id
- OG001
- value
- 87.7
- group Id
- OG002
- spread
- 9.24
- value
- 45.3
- group Id
- OG003
- spread
- 71.4
- value
- 142.00
- group Id
- OG004
- spread
- 67.2
- value
- 158.0
- group Id
- OG005
- spread
- 43.1
- value
- 186.0
- group Id
- OG006
- spread
- 83.1
- value
- 257.0
- group Id
- OG007
- spread
- 120.0
- value
- 186.0
- group Id
- OG008
- spread
- 131.0
- value
- 295.0
- 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
- 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 pharmacokinetic (PK) evaluable population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. '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
- Maximum Observed Plasma Concentration (Cmax) After Single Dose of Alectinib: Phase I
- type
- SECONDARY
- unit Of Measure
- nanograms per milliliter (ng/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice