TriangleNCT04075721 · OUTCOME
Part A: Mutilple Dose: Maximum Observed Plasma Concentration (Cmax) of M3258
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanogram per milliliter (ng/mL)
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Cycle 1 Day 8 or Cycle 1 Day 15: Pre-dose 1, 2, 3, 4, 5, 6, and 8 hours post-dose (each Cycle is of 28 days)
What was measured
Cmax was obtained directly from the concentration versus time curve.
Analysis population: Pharmacokinetic (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
Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) until disease progression.
M3258 10 mg Twice Per Week
Participants received M3258 at a dose of 10 mg orally, 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 | 1 |
| M3258 10 mg Twice Per Week | 3 |
| M3258 20 mg Twice Per Week | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| M3258 10 mg QD | NA | Not reported | NA | NA | Based on pre-specified criteria Geometric Mean and 95% Confidence Interval were not calculated if fewer than 2 participants have reportable parameter values. |
| M3258 10 mg Twice Per Week | 213 | Not reported | 208 | 217 | Not reported |
| M3258 20 mg Twice Per Week | 511 | Not reported | 507 | 516 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Based on pre-specified criteria Geometric Mean and 95% Confidence Interval were not calculated if fewer than 2 participants have reportable parameter values.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 208
- upper Limit
- 217
- value
- 213
- group Id
- OG002
- lower Limit
- 507
- upper Limit
- 516
- value
- 511
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- units
- Participants
- description
- Cmax was obtained directly from the concentration versus time curve.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) until disease progression.
- id
- OG000
- title
- M3258 10 mg QD
- description
- Participants received M3258 at a dose of 10 mg orally, twice per week until disease progression.
- id
- OG001
- title
- M3258 10 mg 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
- OG002
- title
- M3258 20 mg Twice Per Week
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (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 8 or Cycle 1 Day 15: Pre-dose 1, 2, 3, 4, 5, 6, and 8 hours post-dose (each Cycle is of 28 days)
- title
- Part A: Mutilple Dose: Maximum Observed Plasma Concentration (Cmax) of M3258
- type
- SECONDARY
- unit Of Measure
- nanogram per milliliter (ng/mL)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice