TriangleNCT00652626 · OUTCOME
Terminal Phase Half-life of Azacitidine (t½) 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
- hours
- 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 terminal phase half-life of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.
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 | 1.19 | 102.56 | 102.56 | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 0.97 | 43.88 | Not reported | Not reported | Not reported |
Day 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal RF: Azacitidine 75 mg/m^2 | 1.03 | 76.95 | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 1.15 | 53.86 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 102.56
- spread
- 102.56
- value
- 1.19
- group Id
- OG001
- spread
- 43.88
- value
- 0.97
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 76.95
- value
- 1.03
- group Id
- OG001
- spread
- 53.86
- value
- 1.15
- title
- Day 5
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- The terminal phase half-life of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.
- 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
- Terminal Phase Half-life of Azacitidine (t½) After Single and Multiple Doses of Azacitidine
- type
- PRIMARY
- unit Of Measure
- hours
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Preserved source evidence · Not medical advice