TriangleNCT06469138 · OUTCOME
Total Radioactivity - Plasma Maximum Observed Concentration (Cmax)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ngEq/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
What was measured
This endpoint will report the relevant data for the parameters assessed in order to measure total radioactivity in plasma (based upon plasma samples collected at set timepoints during the study). Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Groups in this outcome
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
This was the only treatment arm in the study. Up to 8 participants were to receive a single oral dose of 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib, 30 minutes after starting a standard high-fat breakfast. Bemcentinib: Each 200 mg dose contained approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib and was administered as a single dose on Day 1 of the study.
| Group | Source count |
|---|---|
| Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib | 81.2 | 26.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 26.8
- value
- 81.2
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- This endpoint will report the relevant data for the parameters assessed in order to measure total radioactivity in plasma (based upon plasma samples collected at set timepoints during the study). Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- This was the only treatment arm in the study. Up to 8 participants were to receive a single oral dose of 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib, 30 minutes after starting a standard high-fat breakfast. Bemcentinib: Each 200 mg dose contained approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib and was administered as a single dose on Day 1 of the study.
- id
- OG000
- title
- Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
- param Type
- GEOMETRIC_MEAN
- reporting Status
- POSTED
- time Frame
- Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
- title
- Total Radioactivity - Plasma Maximum Observed Concentration (Cmax)
- type
- PRIMARY
- unit Of Measure
- ngEq/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice