TriangleNCT02082977 · OUTCOME
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) Following Single and Repeat Dose Administration of GSK2816126
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Hour*microgram per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)
What was measured
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following single (Day 1) and repeat dose (Day 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. The analysis was performed on Pharmacokinetic Population which included all participants in the All Subject population for whom a blood sample for pharmacokinetics was analyzed and at least 1 non-missing values was obtained. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Analysis population: Pharmacokinetic Population
Groups in this outcome
Part 1:GSK2816126 50 mg Twice-weekly
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 100 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 200 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 400 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 800 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 1200 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 1800 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 2400 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 3000 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
| Group | Source count |
|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 2 |
| Part 1:GSK2816126 100 mg Twice-weekly | 1 |
| Part 1:GSK2816126 200 mg Twice-weekly | 1 |
| Part 1:GSK2816126 400 mg Twice-weekly | 1 |
| Part 1:GSK2816126 800 mg Twice-weekly | 3 |
| Part 1:GSK2816126 1200 mg Twice-weekly | 4 |
| Part 1:GSK2816126 1800 mg Twice-weekly | 10 |
| Part 1:GSK2816126 2400 mg Twice-weekly | 12 |
| Part 1:GSK2816126 3000 mg Twice-weekly | 7 |
Reported measurements
Day 1; n=2,1,1,1,3,4,10,12,7
| Group | Source count |
|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 2 |
| Part 1:GSK2816126 100 mg Twice-weekly | 1 |
| Part 1:GSK2816126 200 mg Twice-weekly | 1 |
| Part 1:GSK2816126 400 mg Twice-weekly | 1 |
| Part 1:GSK2816126 800 mg Twice-weekly | 3 |
| Part 1:GSK2816126 1200 mg Twice-weekly | 4 |
| Part 1:GSK2816126 1800 mg Twice-weekly | 10 |
| Part 1:GSK2816126 2400 mg Twice-weekly | 12 |
| Part 1:GSK2816126 3000 mg Twice-weekly | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 1.20 | 62 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 100 mg Twice-weekly | 27.20 | NA | Not reported | Not reported | NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. |
| Part 1:GSK2816126 200 mg Twice-weekly | 27.70 | NA | Not reported | Not reported | NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. |
| Part 1:GSK2816126 400 mg Twice-weekly | 11.80 | NA | Not reported | Not reported | NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. |
| Part 1:GSK2816126 800 mg Twice-weekly | 24.18 | 10 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1200 mg Twice-weekly | 85.72 | 91 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1800 mg Twice-weekly | 45.93 | 23 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 2400 mg Twice-weekly | 92.41 | 26 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 3000 mg Twice-weekly | 93.96 | 48 | Not reported | Not reported | Not reported |
Day 15; n=1,1,1,1,3,4,9,11,4
| Group | Source count |
|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 1 |
| Part 1:GSK2816126 100 mg Twice-weekly | 1 |
| Part 1:GSK2816126 200 mg Twice-weekly | 1 |
| Part 1:GSK2816126 400 mg Twice-weekly | 1 |
| Part 1:GSK2816126 800 mg Twice-weekly | 3 |
| Part 1:GSK2816126 1200 mg Twice-weekly | 4 |
| Part 1:GSK2816126 1800 mg Twice-weekly | 9 |
| Part 1:GSK2816126 2400 mg Twice-weekly | 11 |
| Part 1:GSK2816126 3000 mg Twice-weekly | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 3.20 | NA | Not reported | Not reported | NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. |
| Part 1:GSK2816126 100 mg Twice-weekly | 5.70 | NA | Not reported | Not reported | NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. |
| Part 1:GSK2816126 200 mg Twice-weekly | 7.10 | NA | Not reported | Not reported | NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. |
| Part 1:GSK2816126 400 mg Twice-weekly | 13.10 | NA | Not reported | Not reported | NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. |
| Part 1:GSK2816126 800 mg Twice-weekly | 25.82 | 30 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1200 mg Twice-weekly | 53.41 | 14 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1800 mg Twice-weekly | 68.72 | 75 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 2400 mg Twice-weekly | 105.29 | 29 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 3000 mg Twice-weekly | 158.44 | 35 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 62
- value
- 1.20
- comment
- NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
- group Id
- OG001
- spread
- NA
- value
- 27.20
- comment
- NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
- group Id
- OG002
- spread
- NA
- value
- 27.70
- comment
- NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
- group Id
- OG003
- spread
- NA
- value
- 11.80
- group Id
- OG004
- spread
- 10
- value
- 24.18
- group Id
- OG005
- spread
- 91
- value
- 85.72
- group Id
- OG006
- spread
- 23
- value
- 45.93
- group Id
- OG007
- spread
- 26
- value
- 92.41
- group Id
- OG008
- spread
- 48
- value
- 93.96
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 7
- units
- Participants
- title
- Day 1; n=2,1,1,1,3,4,10,12,7
- categories
- measurements
- comment
- NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
- group Id
- OG000
- spread
- NA
- value
- 3.20
- comment
- NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
- group Id
- OG001
- spread
- NA
- value
- 5.70
- comment
- NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
- group Id
- OG002
- spread
- NA
- value
- 7.10
- comment
- NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
- group Id
- OG003
- spread
- NA
- value
- 13.10
- group Id
- OG004
- spread
- 30
- value
- 25.82
- group Id
- OG005
- spread
- 14
- value
- 53.41
- group Id
- OG006
- spread
- 75
- value
- 68.72
- group Id
- OG007
- spread
- 29
- value
- 105.29
- group Id
- OG008
- spread
- 35
- value
- 158.44
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 4
- units
- Participants
- title
- Day 15; n=1,1,1,1,3,4,9,11,4
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 7
- units
- Participants
- description
- Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following single (Day 1) and repeat dose (Day 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. The analysis was performed on Pharmacokinetic Population which included all participants in the All Subject population for whom a blood sample for pharmacokinetics was analyzed and at least 1 non-missing values was obtained. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG000
- title
- Part 1:GSK2816126 50 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG001
- title
- Part 1:GSK2816126 100 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG002
- title
- Part 1:GSK2816126 200 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG003
- title
- Part 1:GSK2816126 400 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG004
- title
- Part 1:GSK2816126 800 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG005
- title
- Part 1:GSK2816126 1200 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG006
- title
- Part 1:GSK2816126 1800 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG007
- title
- Part 1:GSK2816126 2400 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG008
- title
- Part 1:GSK2816126 3000 mg Twice-weekly
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic Population
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)
- title
- Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) Following Single and Repeat Dose Administration of GSK2816126
- type
- SECONDARY
- unit Of Measure
- Hour*microgram per milliliter
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Preserved source evidence · Not medical advice