TriangleNCT04075721 · OUTCOME
Part A: Single Dose: Area Under Plasma Concentration-Time Curve (AUC) From Time Zero to Last Sampling Time (AUC0-t) of M3258
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hour*nanogram per milliliter (h*ng/mL)
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Cycle 1 Day 1: Pre-dose 1, 2, 3, 4, 5, 6, 8 and 24 hours post-dose (each Cycle is of 28 days)
What was measured
Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule. Single dose PK data on Day 1 were summarized by dose level, such that all 10 mg arms were combined as descriptive statistics of PK were only calculated for N greater than (\>) 2 in which a measurement of greater than (\>) lower limit of quantification (LLOQ) represents a valid measurement.
Analysis population: PK analysis set included all participants, who received at least one dose of study intervention, have no clinically important protocol deviations or important events affecting PK, and provide at least one measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Groups in this outcome
M3258 10 mg QD or Twice Per Week
Participants received M3258 at a dose of 10 mg orally, QD or twice per week until disease progression.
M3258 20 mg Twice Per Week
Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.
| Group | Source count |
|---|---|
| M3258 10 mg QD or Twice Per Week | 5 |
| M3258 20 mg Twice Per Week | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| M3258 10 mg QD or Twice Per Week | 2000 | Not reported | 2000 | 2010 | Not reported |
| M3258 20 mg Twice Per Week | 3300 | Not reported | 3300 | 3310 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2000
- upper Limit
- 2010
- value
- 2000
- group Id
- OG001
- lower Limit
- 3300
- upper Limit
- 3310
- value
- 3300
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule. Single dose PK data on Day 1 were summarized by dose level, such that all 10 mg arms were combined as descriptive statistics of PK were only calculated for N greater than (\>) 2 in which a measurement of greater than (\>) lower limit of quantification (LLOQ) represents a valid measurement.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received M3258 at a dose of 10 mg orally, QD or twice per week until disease progression.
- id
- OG000
- title
- M3258 10 mg QD or Twice Per Week
- description
- Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.
- id
- OG001
- title
- M3258 20 mg Twice Per Week
- param Type
- GEOMETRIC_MEAN
- population Description
- PK analysis set included all participants, who received at least one dose of study intervention, have no clinically important protocol deviations or important events affecting PK, and provide at least one measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1: Pre-dose 1, 2, 3, 4, 5, 6, 8 and 24 hours post-dose (each Cycle is of 28 days)
- title
- Part A: Single Dose: Area Under Plasma Concentration-Time Curve (AUC) From Time Zero to Last Sampling Time (AUC0-t) of M3258
- type
- SECONDARY
- unit Of Measure
- hour*nanogram per milliliter (h*ng/mL)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice