TriangleNCT03974022 · OUTCOME
Part A Food Effect: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- h*ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1 and Day 9: 0 (predose) up to 168 hours.
What was measured
Area under the plasma concentration-time-curve from time zero the last quantifiable time point, calculated by the linear up/log down rule, 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: AUC0-t 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 | 8266 | 65.8 | Not reported | Not reported | Not reported |
Part A Food effect: AUC0-t 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 | 10050 | 67.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 65.8
- value
- 8266
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- title
- Part A Food effect: AUC0-t of DZD9008 under Fasted condition
- categories
- measurements
- group Id
- OG000
- spread
- 67.5
- value
- 10050
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- title
- Part A Food effect: AUC0-t of DZD9008 under High-Fat Meal condition
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- Area under the plasma concentration-time-curve from time zero the last quantifiable time point, calculated by the linear up/log down rule, 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: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008
- type
- SECONDARY
- unit Of Measure
- h*ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice