TriangleNCT04075721 · OUTCOME
Part A: Single Dose: Ratio to Baseline in Large Multifunctional Protease 7 (LMP7) Activity at Cycle 1 Day 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ratio
- Interval / dispersion
- Full Range
- Time frame
- Baseline (Pre-dose), 2, 6 and 24 hours post-dose on Cycle 1 Day 1 (each Cycle is of 28 days)
What was measured
Ratio to baseline was calculated dividing post-baseline measurements by the baseline measurement. Single dose Pd 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: The Pharmacodynamic (Pd) population included all participants who received at least one dose of study intervention, had no clinically important protocol deviations or important events affecting Pd, and provide at least one measurable Pd endpoint post-dose. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for specified timepoints.
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 | 3 |
| M3258 20 mg Twice Per Week | 2 |
Reported measurements
Cycle 1 Day 1: 2 hours post-dose
| Group | Source count |
|---|---|
| M3258 10 mg QD or Twice Per Week | 3 |
| M3258 20 mg Twice Per Week | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| M3258 10 mg QD or Twice Per Week | 0.308 | Not reported | 0.21 | 0.41 | Not reported |
| M3258 20 mg Twice Per Week | 0.370 | Not reported | 0.31 | 0.43 | Not reported |
Cycle 1 Day 1: 6 hours post-dose
| Group | Source count |
|---|---|
| M3258 10 mg QD or Twice Per Week | 3 |
| M3258 20 mg Twice Per Week | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| M3258 10 mg QD or Twice Per Week | 0.337 | Not reported | 0.20 | 0.55 | Not reported |
| M3258 20 mg Twice Per Week | 0.178 | Not reported | 0.15 | 0.21 | Not reported |
Cycle 1 Day 1: 24 hours post-dose
| Group | Source count |
|---|---|
| M3258 10 mg QD or Twice Per Week | 2 |
| M3258 20 mg Twice Per Week | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| M3258 10 mg QD or Twice Per Week | 0.387 | Not reported | 0.25 | 0.53 | Not reported |
| M3258 20 mg Twice Per Week | 0.262 | Not reported | 0.16 | 0.36 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.21
- upper Limit
- 0.41
- value
- 0.308
- group Id
- OG001
- lower Limit
- 0.31
- upper Limit
- 0.43
- value
- 0.370
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 1: 2 hours post-dose
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.20
- upper Limit
- 0.55
- value
- 0.337
- group Id
- OG001
- lower Limit
- 0.15
- upper Limit
- 0.21
- value
- 0.178
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 1: 6 hours post-dose
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.25
- upper Limit
- 0.53
- value
- 0.387
- group Id
- OG001
- lower Limit
- 0.16
- upper Limit
- 0.36
- value
- 0.262
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 1: 24 hours post-dose
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- Ratio to baseline was calculated dividing post-baseline measurements by the baseline measurement. Single dose Pd 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
- Full Range
- 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
- MEAN
- population Description
- The Pharmacodynamic (Pd) population included all participants who received at least one dose of study intervention, had no clinically important protocol deviations or important events affecting Pd, and provide at least one measurable Pd endpoint post-dose. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for specified timepoints.
- reporting Status
- POSTED
- time Frame
- Baseline (Pre-dose), 2, 6 and 24 hours post-dose on Cycle 1 Day 1 (each Cycle is of 28 days)
- title
- Part A: Single Dose: Ratio to Baseline in Large Multifunctional Protease 7 (LMP7) Activity at Cycle 1 Day 1
- type
- SECONDARY
- unit Of Measure
- ratio
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Preserved source evidence · Not medical advice