TriangleNCT04442126 · OUTCOME
Assessment of the Terminal Phase (Apparent Elimination) Rate Constant (λz)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- 1/h
- Interval / dispersion
- Standard Deviation
- Time frame
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
Analysis population: Lambda z determined at C1 for all dose levels with the exception of Part A Dose Level 1,2 and 3. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL. The constant Lambda z and its derived parameters meet one of the following conditions: the adjusted regression coefficient is less than 0.8 or the AUC%extrap exceeds 20%.
Groups in this outcome
Part A Dose Level 1 NM21-1480-Q2W 0.15mg
Flat dose level; 0.15mg (Dose Level 1)
Part A Dose Level 2 NM21-1480-Q2W 1.5mg
Flat dose level; 1.5mg (Dose Level 2)
Part A Dose Level 3 NM21-1480-Q2W 8mg
Flat dose level; 8mg (Dose Level 3)
Part A Dose Level 4 NM21-1480-Q2W 24mg
Flat dose level; 24mg (Dose Level 4)
Part A Dose Level 5 NM21-1480-Q2W 80mg
Flat dose level; 80mg (Dose Level 5)
Part A Dose Level 6 NM21-1480-Q2W 240mg
Flat dose level; 240mg (Dose Level 6)
Part A Dose Level 7 NM21-1480-Q2W 800mg
Flat dose level; mg800 (Dose Level 7)
Part A2 NM21-1480-Q2W
This part of the study consisted of a 1400mg flat dose across one cohort.
Part B NM21-1480-Q2W
This part of the study consisted of a 800mg flat dose across three cohorts.
| Group | Source count |
|---|---|
| Part A Dose Level 1 NM21-1480-Q2W 0.15mg | 0 |
| Part A Dose Level 2 NM21-1480-Q2W 1.5mg | 0 |
| Part A Dose Level 3 NM21-1480-Q2W 8mg | 0 |
| Part A Dose Level 4 NM21-1480-Q2W 24mg | 3 |
| Part A Dose Level 5 NM21-1480-Q2W 80mg | 5 |
| Part A Dose Level 6 NM21-1480-Q2W 240mg | 3 |
| Part A Dose Level 7 NM21-1480-Q2W 800mg | 8 |
| Part A2 NM21-1480-Q2W | 4 |
| Part B NM21-1480-Q2W | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Dose Level 4 NM21-1480-Q2W 24mg | 0.007163 | 0.002300 | Not reported | Not reported | Not reported |
| Part A Dose Level 5 NM21-1480-Q2W 80mg | 0.005417 | 0.002940 | Not reported | Not reported | Not reported |
| Part A Dose Level 6 NM21-1480-Q2W 240mg | 0.003352 | 0.001460 | Not reported | Not reported | Not reported |
| Part A Dose Level 7 NM21-1480-Q2W 800mg | 0.003522 | 0.0007292 | Not reported | Not reported | Not reported |
| Part A2 NM21-1480-Q2W | 0.002923 | 0.001239 | Not reported | Not reported | Not reported |
| Part B NM21-1480-Q2W | 0.002840 | 0.0006234 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG003
- spread
- 0.002300
- value
- 0.007163
- group Id
- OG004
- spread
- 0.002940
- value
- 0.005417
- group Id
- OG005
- spread
- 0.001460
- value
- 0.003352
- group Id
- OG006
- spread
- 0.0007292
- value
- 0.003522
- group Id
- OG007
- spread
- 0.001239
- value
- 0.002923
- group Id
- OG008
- spread
- 0.0006234
- value
- 0.002840
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 4
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Flat dose level; 0.15mg (Dose Level 1)
- id
- OG000
- title
- Part A Dose Level 1 NM21-1480-Q2W 0.15mg
- description
- Flat dose level; 1.5mg (Dose Level 2)
- id
- OG001
- title
- Part A Dose Level 2 NM21-1480-Q2W 1.5mg
- description
- Flat dose level; 8mg (Dose Level 3)
- id
- OG002
- title
- Part A Dose Level 3 NM21-1480-Q2W 8mg
- description
- Flat dose level; 24mg (Dose Level 4)
- id
- OG003
- title
- Part A Dose Level 4 NM21-1480-Q2W 24mg
- description
- Flat dose level; 80mg (Dose Level 5)
- id
- OG004
- title
- Part A Dose Level 5 NM21-1480-Q2W 80mg
- description
- Flat dose level; 240mg (Dose Level 6)
- id
- OG005
- title
- Part A Dose Level 6 NM21-1480-Q2W 240mg
- description
- Flat dose level; mg800 (Dose Level 7)
- id
- OG006
- title
- Part A Dose Level 7 NM21-1480-Q2W 800mg
- description
- This part of the study consisted of a 1400mg flat dose across one cohort.
- id
- OG007
- title
- Part A2 NM21-1480-Q2W
- description
- This part of the study consisted of a 800mg flat dose across three cohorts.
- id
- OG008
- title
- Part B NM21-1480-Q2W
- param Type
- MEAN
- population Description
- Lambda z determined at C1 for all dose levels with the exception of Part A Dose Level 1,2 and 3. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL. The constant Lambda z and its derived parameters meet one of the following conditions: the adjusted regression coefficient is less than 0.8 or the AUC%extrap exceeds 20%.
- reporting Status
- POSTED
- time Frame
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
- title
- Assessment of the Terminal Phase (Apparent Elimination) Rate Constant (λz)
- type
- SECONDARY
- unit Of Measure
- 1/h
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice