TriangleNCT02082977 · OUTCOME
Part 1: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following 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, 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 15 (Each cycle was of 28 days)
What was measured
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-tau) following repeat (Day 15) dose administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
Analysis population: Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.
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 | 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 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 2.90 | 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 | 12.30 | 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 | 26.85 | 25 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1200 mg Twice-weekly | 53.66 | 14 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1800 mg Twice-weekly | 59.70 | 25 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 2400 mg Twice-weekly | 111.32 | 25 | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 3000 mg Twice-weekly | 157.88 | 36 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- 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
- 2.90
- 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
- 12.30
- group Id
- OG004
- spread
- 25
- value
- 26.85
- group Id
- OG005
- spread
- 14
- value
- 53.66
- group Id
- OG006
- spread
- 25
- value
- 59.70
- group Id
- OG007
- spread
- 25
- value
- 111.32
- group Id
- OG008
- spread
- 36
- value
- 157.88
- 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
- description
- Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-tau) following repeat (Day 15) dose administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
- 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. Only those participants with data available at specific time point were analyzed.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.5, 1, 2, 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 15 (Each cycle was of 28 days)
- title
- Part 1: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK2816126
- type
- SECONDARY
- unit Of Measure
- Hour*Microgram per milliliter
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Preserved source evidence · Not medical advice