TriangleNCT02793128 · OUTCOME
Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation of UGN-101
What was measured
Cmax: maximum plasma concentration Analysis of individual plasma concentration versus time profiles showed that at 6 hours post instillation, the plasma concentrations of all 6 patients were below 2 ng/mL, with the plasma concentration of one patient dropping below the LOQ (i.e., \< 0.100 ng/mL). The mean Cmax was 6.24 ng/mL (range: 2.43 to 12.80 ng/mL). The highest individual observed Cmax value of 12.80 ng/mL was 187-fold and 40 fold lower than the observed Cmax level following an intravenous bolus dose of 30 mg or 10 mg mitomycin (2.4 μg/mL and 0.52 μg/mL, respectively) and is 31 fold lower than the threshold value of 400 ng/mL for myelosuppression observed with mitomycin.
Analysis population: PK Analysis Set: Consisted of patients who signed consent for PK and had sufficient PK data for the determination of PK parameters.
Groups in this outcome
Pharmacokinetic Population
The PK profiles of the first UGN-101 instillation in the blood were to be examined for the first 6 patients.
| Group | Source count |
|---|---|
| Pharmacokinetic Population | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pharmacokinetic Population | 6.24 | Not reported | 2.43 | 12.80 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.43
- upper Limit
- 12.80
- value
- 6.24
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- Cmax: maximum plasma concentration Analysis of individual plasma concentration versus time profiles showed that at 6 hours post instillation, the plasma concentrations of all 6 patients were below 2 ng/mL, with the plasma concentration of one patient dropping below the LOQ (i.e., \< 0.100 ng/mL). The mean Cmax was 6.24 ng/mL (range: 2.43 to 12.80 ng/mL). The highest individual observed Cmax value of 12.80 ng/mL was 187-fold and 40 fold lower than the observed Cmax level following an intravenous bolus dose of 30 mg or 10 mg mitomycin (2.4 μg/mL and 0.52 μg/mL, respectively) and is 31 fold lower than the threshold value of 400 ng/mL for myelosuppression observed with mitomycin.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- The PK profiles of the first UGN-101 instillation in the blood were to be examined for the first 6 patients.
- id
- OG000
- title
- Pharmacokinetic Population
- param Type
- MEAN
- population Description
- PK Analysis Set: Consisted of patients who signed consent for PK and had sufficient PK data for the determination of PK parameters.
- reporting Status
- POSTED
- time Frame
- Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation of UGN-101
- title
- Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients.
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice