TriangleNCT03974022 · OUTCOME
Part A Food Effect: Maximum Plasma Concentration (Cmax) of DZD9008
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1 and Day 9: 0 (predose) up to 168 hours.
What was measured
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose, in the fasted or fed state.
Analysis population: All participants from the food effect cohort for whom a PK profile is available on at least one of the fed and fasted dosing days.
Groups in this outcome
Part A Food Effect Cohort: Sunvozertinib 300 mg
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted or High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal or Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
| Group | Source count |
|---|---|
| Part A Food Effect Cohort: Sunvozertinib 300 mg | 12 |
Reported measurements
Part A Food effect: Maximum Plasma Concentration (Cmax) of DZD9008 under Fasted condition
| Group | Source count |
|---|---|
| Part A Food Effect Cohort: Sunvozertinib 300 mg | 11 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Food Effect Cohort: Sunvozertinib 300 mg | 307.0 | 59.6 | Not reported | Not reported | Not reported |
Part A Food effect: Maximum Plasma Concentration (Cmax) of DZD9008 under High-Fat Meal condition
| Group | Source count |
|---|---|
| Part A Food Effect Cohort: Sunvozertinib 300 mg | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Food Effect Cohort: Sunvozertinib 300 mg | 331.6 | 48.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 59.6
- value
- 307.0
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- title
- Part A Food effect: Maximum Plasma Concentration (Cmax) of DZD9008 under Fasted condition
- categories
- measurements
- group Id
- OG000
- spread
- 48.8
- value
- 331.6
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- title
- Part A Food effect: Maximum Plasma Concentration (Cmax) of DZD9008 under High-Fat Meal condition
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose, in the fasted or fed state.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted or High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal or Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
- id
- OG000
- title
- Part A Food Effect Cohort: Sunvozertinib 300 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- All participants from the food effect cohort for whom a PK profile is available on at least one of the fed and fasted dosing days.
- reporting Status
- POSTED
- time Frame
- Day 1 and Day 9: 0 (predose) up to 168 hours.
- title
- Part A Food Effect: Maximum Plasma Concentration (Cmax) of DZD9008
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice