TriangleNCT00652626 · OUTCOME
Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose After Single and Multiple Doses of Azacitidine
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*hr/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose
What was measured
The effect of renal impairment on azacitidine pharmacokinetics was analyzed by comparing PK parameters obtained on Days 1 and 5 from participants with severe renal impairment and those with normal renal function. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule.
Analysis population: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.
Groups in this outcome
Normal RF: Azacitidine 75 mg/m^2
Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
| Group | Source count |
|---|---|
| Normal RF: Azacitidine 75 mg/m^2 | 6 |
| Severe RI: Azacitidine 75 mg/m^2 | 6 |
Reported measurements
Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal RF: Azacitidine 75 mg/m^2 | 921.87 | 39.15 | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 1558.32 | 64.95 | Not reported | Not reported | Not reported |
Day 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal RF: Azacitidine 75 mg/m^2 | 843.03 | 12.00 | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 1183.61 | 51.92 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 39.15
- value
- 921.87
- group Id
- OG001
- spread
- 64.95
- value
- 1558.32
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 12.00
- value
- 843.03
- group Id
- OG001
- spread
- 51.92
- value
- 1183.61
- title
- Day 5
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- The effect of renal impairment on azacitidine pharmacokinetics was analyzed by comparing PK parameters obtained on Days 1 and 5 from participants with severe renal impairment and those with normal renal function. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
- id
- OG000
- title
- Normal RF: Azacitidine 75 mg/m^2
- description
- Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
- id
- OG001
- title
- Severe RI: Azacitidine 75 mg/m^2
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.
- reporting Status
- POSTED
- time Frame
- Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose
- title
- Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose After Single and Multiple Doses of Azacitidine
- type
- PRIMARY
- unit Of Measure
- ng*hr/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice