TriangleNCT02211014 · OUTCOME
Pharmacokinetic (PK) Parameters Calculated for Acalabrutinib: AUC0-4, AUClast, AUCINF, Cmax, Tmax, λz, t1/2, CL/F, and Vz/F. PK Parameters Calculated for Dexamethasone: Tmax, Cmax, AUC0-4 and AUClast.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percentage of CV
- Interval / dispersion
- Standard Deviation
- Time frame
- On Days 1 and 22: pre-dose, and at 0.5, 0.75, 1, 2, 4, and 6 hours after the morning dose. On Days 8, 15, and 28: pre-dose and 1 hour after the morning dose.
What was measured
The plasma PK of study drug was characterized using noncompartmental analysis. PK parameters were calculated whenever possible, from plasma concentrations of acalabrutinib. Missing dates or times could have been imputed for PK and pharmacodynamic (PD) samples if the missing values could be established with an acceptable level of accuracy based on other information obtained during the visit in question. If PK and PD sampling for a 33 Final Clinical Study Report Drug Substance Acalabrutinib Study Code ACE-MY-001 Edition Number 2 Date 31 October 2018 given subject was not performed according to protocol, the subject could have been excluded from the PK and PD analyses. The PK parameters were tabulated and summarized using descriptive statistics. For each PD variable, the concentration at each assessment was described. The change from baseline to each assessment was summarized. As appropriate the on treatment values were compared with the pretreatment baseline values using paired t-tests.
Analysis population: Day 1: 24 (of 27 subjects enrolled) were equally randomized (1:1 ratio) into two cohorts to receive Acalabrutinib (12 in Cohort 1), or with dexamethasone (12 in Cohort 2). Day 22: 17 (of 24) subjects with PK data were remaining: 9 in Cohort 1 and 8 in Cohort 2. Seven subjects discontinued the study prior to Day 22.
Groups in this outcome
Cohort 1 - Day 1
Acalabrutinib 100 mg twice daily (bid) continuously
Cohort 2 - Day 1
Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
Cohort 1 - Day 22
Acalabrutinib 100 mg twice daily (bid) continuously
Cohort 2 - Day 22
Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
| Group | Source count |
|---|---|
| Cohort 1 - Day 1 | 12 |
| Cohort 2 - Day 1 | 12 |
| Cohort 1 - Day 22 | 9 |
| Cohort 2 - Day 22 | 8 |
Reported measurements
Cmax (ng/mL) - the maximum concentration observed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - Day 1 | 524 | 112 | Not reported | Not reported | Not reported |
| Cohort 2 - Day 1 | 437 | 91.5 | Not reported | Not reported | Not reported |
| Cohort 1 - Day 22 | 271 | 103 | Not reported | Not reported | Not reported |
| Cohort 2 - Day 22 | 607 | 90.8 | Not reported | Not reported | Not reported |
AUC (area under the curve)_0-4 (hr*ng/mL)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - Day 1 | 604 | 72.9 | Not reported | Not reported | Not reported |
| Cohort 2 - Day 1 | 621 | 64 | Not reported | Not reported | Not reported |
| Cohort 1 - Day 22 | 390 | 105 | Not reported | Not reported | Not reported |
| Cohort 2 - Day 22 | 766 | 60.5 | Not reported | Not reported | Not reported |
AUC_last (hr*ng/mL)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - Day 1 | 638 | 69.5 | Not reported | Not reported | Not reported |
| Cohort 2 - Day 1 | 675 | 56.9 | Not reported | Not reported | Not reported |
| Cohort 1 - Day 22 | 423 | 102 | Not reported | Not reported | Not reported |
| Cohort 2 - Day 22 | 812 | 58.3 | Not reported | Not reported | Not reported |
AUC_INF (infinity) (hr*ng/mL)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - Day 1 | 754 | 67.8 | Not reported | Not reported | Not reported |
| Cohort 2 - Day 1 | 732 | 63.1 | Not reported | Not reported | Not reported |
| Cohort 1 - Day 22 | 411 | 111 | Not reported | Not reported | Not reported |
| Cohort 2 - Day 22 | 826 | 62.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 112
- value
- 524
- group Id
- OG001
- spread
- 91.5
- value
- 437
- group Id
- OG002
- spread
- 103
- value
- 271
- group Id
- OG003
- spread
- 90.8
- value
- 607
- title
- Cmax (ng/mL) - the maximum concentration observed
- categories
- measurements
- group Id
- OG000
- spread
- 72.9
- value
- 604
- group Id
- OG001
- spread
- 64
- value
- 621
- group Id
- OG002
- spread
- 105
- value
- 390
- group Id
- OG003
- spread
- 60.5
- value
- 766
- title
- AUC (area under the curve)_0-4 (hr*ng/mL)
- categories
- measurements
- group Id
- OG000
- spread
- 69.5
- value
- 638
- group Id
- OG001
- spread
- 56.9
- value
- 675
- group Id
- OG002
- spread
- 102
- value
- 423
- group Id
- OG003
- spread
- 58.3
- value
- 812
- title
- AUC_last (hr*ng/mL)
- categories
- measurements
- group Id
- OG000
- spread
- 67.8
- value
- 754
- group Id
- OG001
- spread
- 63.1
- value
- 732
- group Id
- OG002
- spread
- 111
- value
- 411
- group Id
- OG003
- spread
- 62.6
- value
- 826
- title
- AUC_INF (infinity) (hr*ng/mL)
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 8
- units
- Participants
- description
- The plasma PK of study drug was characterized using noncompartmental analysis. PK parameters were calculated whenever possible, from plasma concentrations of acalabrutinib. Missing dates or times could have been imputed for PK and pharmacodynamic (PD) samples if the missing values could be established with an acceptable level of accuracy based on other information obtained during the visit in question. If PK and PD sampling for a 33 Final Clinical Study Report Drug Substance Acalabrutinib Study Code ACE-MY-001 Edition Number 2 Date 31 October 2018 given subject was not performed according to protocol, the subject could have been excluded from the PK and PD analyses. The PK parameters were tabulated and summarized using descriptive statistics. For each PD variable, the concentration at each assessment was described. The change from baseline to each assessment was summarized. As appropriate the on treatment values were compared with the pretreatment baseline values using paired t-tests.
- dispersion Type
- Standard Deviation
- groups
- description
- Acalabrutinib 100 mg twice daily (bid) continuously
- id
- OG000
- title
- Cohort 1 - Day 1
- description
- Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
- id
- OG001
- title
- Cohort 2 - Day 1
- description
- Acalabrutinib 100 mg twice daily (bid) continuously
- id
- OG002
- title
- Cohort 1 - Day 22
- description
- Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
- id
- OG003
- title
- Cohort 2 - Day 22
- param Type
- MEAN
- population Description
- Day 1: 24 (of 27 subjects enrolled) were equally randomized (1:1 ratio) into two cohorts to receive Acalabrutinib (12 in Cohort 1), or with dexamethasone (12 in Cohort 2). Day 22: 17 (of 24) subjects with PK data were remaining: 9 in Cohort 1 and 8 in Cohort 2. Seven subjects discontinued the study prior to Day 22.
- reporting Status
- POSTED
- time Frame
- On Days 1 and 22: pre-dose, and at 0.5, 0.75, 1, 2, 4, and 6 hours after the morning dose. On Days 8, 15, and 28: pre-dose and 1 hour after the morning dose.
- title
- Pharmacokinetic (PK) Parameters Calculated for Acalabrutinib: AUC0-4, AUClast, AUCINF, Cmax, Tmax, λz, t1/2, CL/F, and Vz/F. PK Parameters Calculated for Dexamethasone: Tmax, Cmax, AUC0-4 and AUClast.
- type
- SECONDARY
- unit Of Measure
- percentage of CV
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Preserved source evidence · Not medical advice