TriangleNCT02099539 · OUTCOME
Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Volume of Distribution (Vz/F)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mL/kg
- Interval / dispersion
- Full Range
- Time frame
- PK timepoint up to 72 hours +/- 6 hours
What was measured
Apparent volume of distribution is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration
Analysis population: Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects In addition, 6 out of 7 SC patients (Cohorts 5 and 6) had insufficient measurable post-tmax sampling to allow for evaluation of the terminal phase-dependent PK parameters (ie, t½, CL/F, Vz/F, AUC0-168, AUC0-∞).
Groups in this outcome
Cohort 5: N-803 - SQ 10 ug/kg
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
Cohort 6: N-803 - SQ 15 ug/kg
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
| Group | Source count |
|---|---|
| Cohort 5: N-803 - SQ 10 ug/kg | 0 |
| Cohort 6: N-803 - SQ 15 ug/kg | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 6: N-803 - SQ 15 ug/kg | 23500 | Not reported | 23500 | 23500 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 23500
- upper Limit
- 23500
- value
- 23500
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- Apparent volume of distribution is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration
- dispersion Type
- Full Range
- groups
- description
- N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
- id
- OG000
- title
- Cohort 5: N-803 - SQ 10 ug/kg
- description
- N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
- id
- OG001
- title
- Cohort 6: N-803 - SQ 15 ug/kg
- param Type
- MEAN
- population Description
- Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects In addition, 6 out of 7 SC patients (Cohorts 5 and 6) had insufficient measurable post-tmax sampling to allow for evaluation of the terminal phase-dependent PK parameters (ie, t½, CL/F, Vz/F, AUC0-168, AUC0-∞).
- reporting Status
- POSTED
- time Frame
- PK timepoint up to 72 hours +/- 6 hours
- title
- Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Volume of Distribution (Vz/F)
- type
- SECONDARY
- unit Of Measure
- mL/kg
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice