TriangleNCT01915498 · OUTCOME
Phase 1 and 2: AUC From Time Zero to 8 Hours Postdose (AUC0-8) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib 100 mg QD
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
- Day -3 (Phase 1 only) predose and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose or Cycle 1 Day 1 (Phase 2) and Cycle 2 Day 1 (Phase 1 & 2) at predose and 2, 4, 6, and 8 hours post-dose.
What was measured
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for single dose PK analysis, and underwent PK assessments on Cycle 2, Day 1 for multiple dose (steady-state) PK analysis. Participants in Phase 2 underwent PK assessments on Cycle 1, Day 1 for single dose analysis and on Cycle 2, Day 1 for multiple dose (steady-state) analysis. 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 8 hours post-dose (AUC0-8) was calculated using the linear trapezoidal rule.
Analysis population: Participants who received enasidenib on Day -3 or Cycle 1, Day 1 and Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took \< 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. Participants in Phase 1 and 2 who received enasidenib 100 mg QD are combined for the analysis.
Groups in this outcome
Phase 1 and 2: Enasidenib 100 mg QD
Participants in Phase 1 and 2 who received 100 mg enasidenib 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 1 and 2: Enasidenib 100 mg QD | 164 |
Reported measurements
Day -3 / Cycle 1, Day 1
| Group | Source count |
|---|---|
| Phase 1 and 2: Enasidenib 100 mg QD | 143 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 and 2: Enasidenib 100 mg QD | 304 | 96.0 | Not reported | Not reported | Not reported |
Cycle 2, Day 1
| Group | Source count |
|---|---|
| Phase 1 and 2: Enasidenib 100 mg QD | 164 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 and 2: Enasidenib 100 mg QD | 7555 | 43.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 96.0
- value
- 304
- denoms
- counts
- group Id
- OG000
- value
- 143
- units
- Participants
- title
- Day -3 / Cycle 1, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 43.6
- value
- 7555
- denoms
- counts
- group Id
- OG000
- value
- 164
- units
- Participants
- title
- Cycle 2, Day 1
- denoms
- counts
- group Id
- OG000
- value
- 164
- units
- Participants
- description
- The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for single dose PK analysis, and underwent PK assessments on Cycle 2, Day 1 for multiple dose (steady-state) PK analysis. Participants in Phase 2 underwent PK assessments on Cycle 1, Day 1 for single dose analysis and on Cycle 2, Day 1 for multiple dose (steady-state) analysis. 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 8 hours post-dose (AUC0-8) was calculated using the linear trapezoidal rule.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants in Phase 1 and 2 who received 100 mg enasidenib 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 1 and 2: Enasidenib 100 mg QD
- param Type
- GEOMETRIC_MEAN
- population Description
- Participants who received enasidenib on Day -3 or Cycle 1, Day 1 and Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took \< 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. Participants in Phase 1 and 2 who received enasidenib 100 mg QD are combined for the analysis.
- reporting Status
- POSTED
- time Frame
- Day -3 (Phase 1 only) predose and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose or Cycle 1 Day 1 (Phase 2) and Cycle 2 Day 1 (Phase 1 & 2) at predose and 2, 4, 6, and 8 hours post-dose.
- title
- Phase 1 and 2: AUC From Time Zero to 8 Hours Postdose (AUC0-8) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib 100 mg QD
- type
- SECONDARY
- unit Of Measure
- ng*h/mL
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Preserved source evidence · Not medical advice