TriangleNCT00908037 · OUTCOME
Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- micrograms per milliliter (ug/mL)
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From Day 1 of treatment up to Study Week 31
What was measured
The maximum observed concentration (Cmax) and the concentration at the end of the dosing interval (Ct) data were collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of Cmax and Ct were estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.
Analysis population: Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.
Groups in this outcome
Eltrombopag Cohort 1- 12-17 Years
Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
Eltrombopag Cohort 2 - 6-11 Years
Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing \<27 kilograms (kg) started at 12.5mg QD and par weighing \>=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing \<27kg started at 25mg QD and par weighing \>=27kg started at 50mg QD. Par of East Asian ancestry weighing \<27kg began at 12.5mg QD and those \>=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
Eltrombopag Cohort 3 - 1-5 Years
Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
| Group | Source count |
|---|---|
| Eltrombopag Cohort 1- 12-17 Years | 29 |
| Eltrombopag Cohort 2 - 6-11 Years | 30 |
| Eltrombopag Cohort 3 - 1-5 Years | 19 |
Reported measurements
Cmax
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Eltrombopag Cohort 1- 12-17 Years | 6.65 | Not reported | 5.87 | 7.53 | Not reported |
| Eltrombopag Cohort 2 - 6-11 Years | 9.19 | Not reported | 8.18 | 10.3 | Not reported |
| Eltrombopag Cohort 3 - 1-5 Years | 10.7 | Not reported | 9.24 | 12.5 | Not reported |
Ct
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Eltrombopag Cohort 1- 12-17 Years | 2.42 | Not reported | 1.97 | 2.98 | Not reported |
| Eltrombopag Cohort 2 - 6-11 Years | 2.95 | Not reported | 2.41 | 3.60 | Not reported |
| Eltrombopag Cohort 3 - 1-5 Years | 2.91 | Not reported | 2.14 | 3.96 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.87
- upper Limit
- 7.53
- value
- 6.65
- group Id
- OG001
- lower Limit
- 8.18
- upper Limit
- 10.3
- value
- 9.19
- group Id
- OG002
- lower Limit
- 9.24
- upper Limit
- 12.5
- value
- 10.7
- title
- Cmax
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.97
- upper Limit
- 2.98
- value
- 2.42
- group Id
- OG001
- lower Limit
- 2.41
- upper Limit
- 3.60
- value
- 2.95
- group Id
- OG002
- lower Limit
- 2.14
- upper Limit
- 3.96
- value
- 2.91
- title
- Ct
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 19
- units
- Participants
- description
- The maximum observed concentration (Cmax) and the concentration at the end of the dosing interval (Ct) data were collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of Cmax and Ct were estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
- id
- OG000
- title
- Eltrombopag Cohort 1- 12-17 Years
- description
- Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing \<27 kilograms (kg) started at 12.5mg QD and par weighing \>=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing \<27kg started at 25mg QD and par weighing \>=27kg started at 50mg QD. Par of East Asian ancestry weighing \<27kg began at 12.5mg QD and those \>=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
- id
- OG001
- title
- Eltrombopag Cohort 2 - 6-11 Years
- description
- Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
- id
- OG002
- title
- Eltrombopag Cohort 3 - 1-5 Years
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.
- reporting Status
- POSTED
- time Frame
- From Day 1 of treatment up to Study Week 31
- title
- Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3.
- type
- SECONDARY
- unit Of Measure
- micrograms per milliliter (ug/mL)
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Preserved source evidence · Not medical advice