TriangleNCT01915498 · OUTCOME
Phase 2: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*h/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.
What was measured
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) was calculated using the linear trapezoidal rule.
Analysis population: Participants who received enasidenib on Cycle 1, Day 1 or Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1.
Groups in this outcome
Phase 2: Enasidenib 100 mg QD
Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase 2: Enasidenib 100 mg QD | 91 |
Reported measurements
Cycle 1, Day 1
| Group | Source count |
|---|---|
| Phase 2: Enasidenib 100 mg QD | 91 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Enasidenib 100 mg QD | 829 | 138.1 | Not reported | Not reported | Not reported |
Cycle 2, Day 1
| Group | Source count |
|---|---|
| Phase 2: Enasidenib 100 mg QD | 68 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Enasidenib 100 mg QD | 16593 | 81.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 138.1
- value
- 829
- denoms
- counts
- group Id
- OG000
- value
- 91
- units
- Participants
- title
- Cycle 1, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 81.8
- value
- 16593
- denoms
- counts
- group Id
- OG000
- value
- 68
- units
- Participants
- title
- Cycle 2, Day 1
- denoms
- counts
- group Id
- OG000
- value
- 91
- units
- Participants
- description
- AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) was calculated using the linear trapezoidal rule.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG000
- title
- Phase 2: Enasidenib 100 mg QD
- param Type
- GEOMETRIC_MEAN
- population Description
- Participants who received enasidenib on Cycle 1, Day 1 or Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.
- title
- Phase 2: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
- type
- SECONDARY
- unit Of Measure
- ng*h/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice