NCT02603172 · OUTCOME
Part A: Mean Change From Baseline in Temperature
A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis · Source last updated 2019-09-23
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Celsius
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
What was measured
Temperature was measured in semi-supine position after 5 min rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.
Analysis population: Safety population.
Groups in this outcome
Part A: GSK3039294 200 mg
Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.
Part A: GSK3039294 600 mg
Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.
Part A: GSK3039294 1200 mg
Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part A: GSK3039294 200 mg | 8 |
|---|
| Part A: GSK3039294 600 mg | 16 |
|---|
| Part A: GSK3039294 1200 mg | 8 |
|---|
Reported measurements
15 minutes
Values in Celsius · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: GSK3039294 200 mg | -0.18 | 0.292 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 600 mg | -0.00 | 0.339 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 1200 mg | 0.10 | 0.239 | Not reported | Not reported | Not reported |
|---|
30 minutes
Values in Celsius · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: GSK3039294 200 mg | -0.14 | 0.374 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 600 mg | -0.02 | 0.369 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 1200 mg | 0.09 | 0.253 | Not reported | Not reported | Not reported |
|---|
1 hour
Values in Celsius · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: GSK3039294 200 mg | -0.26 | 0.469 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 600 mg | 0.09 | 0.380 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 1200 mg | 0.17 | 0.255 | Not reported | Not reported | Not reported |
|---|
2 hour
Values in Celsius · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: GSK3039294 200 mg | -0.06 | 0.288 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 600 mg | 0.09 | 0.278 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 1200 mg | 0.21 | 0.230 | Not reported | Not reported | Not reported |
|---|
4 hour
Values in Celsius · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: GSK3039294 200 mg | 0.24 | 0.329 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 600 mg | 0.27 | 0.453 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 1200 mg | 0.34 | 0.350 | Not reported | Not reported | Not reported |
|---|
6 hour
Values in Celsius · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: GSK3039294 200 mg | 0.24 | 0.250 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 600 mg | 0.53 | 0.318 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 1200 mg | 0.45 | 0.334 | Not reported | Not reported | Not reported |
|---|
8 hour
Values in Celsius · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: GSK3039294 200 mg | -0.00 | 0.438 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 600 mg | 0.37 | 0.427 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 1200 mg | 0.47 | 0.381 | Not reported | Not reported | Not reported |
|---|
12 hour
Values in Celsius · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: GSK3039294 200 mg | 0.10 | 0.463 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 600 mg | 0.19 | 0.486 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 1200 mg | 0.36 | 0.534 | Not reported | Not reported | Not reported |
|---|
24 hour
Values in Celsius · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: GSK3039294 200 mg | 0.09 | 0.439 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 600 mg | 0.12 | 0.276 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 1200 mg | 0.08 | 0.271 | Not reported | Not reported | Not reported |
|---|
48 hour
Values in Celsius · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: GSK3039294 200 mg | 0.05 | 0.417 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 600 mg | 0.13 | 0.334 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 1200 mg | 0.35 | 0.233 | Not reported | Not reported | Not reported |
|---|
72 hour
Values in Celsius · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part A: GSK3039294 200 mg | 0.17 | 0.413 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 600 mg | 0.20 | 0.310 | Not reported | Not reported | Not reported |
|---|
| Part A: GSK3039294 1200 mg | 0.43 | 0.282 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.292
- value
- -0.18
- group Id
- OG001
- spread
- 0.339
- value
- -0.00
- group Id
- OG002
- spread
- 0.239
- value
- 0.10
- title
- 15 minutes
- categories
- measurements
- group Id
- OG000
- spread
- 0.374
- value
- -0.14
- group Id
- OG001
- spread
- 0.369
- value
- -0.02
- group Id
- OG002
- spread
- 0.253
- value
- 0.09
- title
- 30 minutes
- categories
- measurements
- group Id
- OG000
- spread
- 0.469
- value
- -0.26
- group Id
- OG001
- spread
- 0.380
- value
- 0.09
- group Id
- OG002
- spread
- 0.255
- value
- 0.17
- title
- 1 hour
- categories
- measurements
- group Id
- OG000
- spread
- 0.288
- value
- -0.06
- group Id
- OG001
- spread
- 0.278
- value
- 0.09
- group Id
- OG002
- spread
- 0.230
- value
- 0.21
- title
- 2 hour
- categories
- measurements
- group Id
- OG000
- spread
- 0.329
- value
- 0.24
- group Id
- OG001
- spread
- 0.453
- value
- 0.27
- group Id
- OG002
- spread
- 0.350
- value
- 0.34
- title
- 4 hour
- categories
- measurements
- group Id
- OG000
- spread
- 0.250
- value
- 0.24
- group Id
- OG001
- spread
- 0.318
- value
- 0.53
- group Id
- OG002
- spread
- 0.334
- value
- 0.45
- title
- 6 hour
- categories
- measurements
- group Id
- OG000
- spread
- 0.438
- value
- -0.00
- group Id
- OG001
- spread
- 0.427
- value
- 0.37
- group Id
- OG002
- spread
- 0.381
- value
- 0.47
- title
- 8 hour
- categories
- measurements
- group Id
- OG000
- spread
- 0.463
- value
- 0.10
- group Id
- OG001
- spread
- 0.486
- value
- 0.19
- group Id
- OG002
- spread
- 0.534
- value
- 0.36
- title
- 12 hour
- categories
- measurements
- group Id
- OG000
- spread
- 0.439
- value
- 0.09
- group Id
- OG001
- spread
- 0.276
- value
- 0.12
- group Id
- OG002
- spread
- 0.271
- value
- 0.08
- title
- 24 hour
- categories
- measurements
- group Id
- OG000
- spread
- 0.417
- value
- 0.05
- group Id
- OG001
- spread
- 0.334
- value
- 0.13
- group Id
- OG002
- spread
- 0.233
- value
- 0.35
- title
- 48 hour
- categories
- measurements
- group Id
- OG000
- spread
- 0.413
- value
- 0.17
- group Id
- OG001
- spread
- 0.310
- value
- 0.20
- group Id
- OG002
- spread
- 0.282
- value
- 0.43
- title
- 72 hour
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 8
- units
- Participants
- description
- Temperature was measured in semi-supine position after 5 min rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.
- id
- OG000
- title
- Part A: GSK3039294 200 mg
- description
- Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.
- id
- OG001
- title
- Part A: GSK3039294 600 mg
- description
- Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.
- id
- OG002
- title
- Part A: GSK3039294 1200 mg
- param Type
- MEAN
- population Description
- Safety population.
- reporting Status
- POSTED
- time Frame
- Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
- title
- Part A: Mean Change From Baseline in Temperature
- type
- PRIMARY
- unit Of Measure
- Celsius
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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