TriangleNCT01915498 · OUTCOME
Phase 1: Percent Change From Baseline for Area Under the Effect Concentration Time Curve From Time 0 to 10 Hours Postdose (%BAUEC0-10) of 2-hydroxyglutarate (2-HG) on Day -3
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change
- Interval / dispersion
- Standard Deviation
- Time frame
- Screening visit, Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, and 10 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). Plasma 2-HG was measured using qualified LC-MS/MS in order to characterize the pharmacodynamic (PD) effects of enasidenib; the LLOQ was 30.0 ng/mL. Area under the effect concentration time curve from time point zero (predose) up to 10 hours postdose (AUEC0-10) was calculated using the linear trapezoid rule. Percent change from Baseline for AUEC0-10 was calculated as (AUEC0-10 minus \[Baseline\*Tlast\]) / (Baseline\*Tlast) \* 100, where Tlast corresponded to 10 hours and Baseline was equal to the average of the Screening and Day -3 (predose) 2-HG values. Data reported are the arithmetic mean and relative standard deviation expressed as a percentage.
Analysis population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PD parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
Groups in this outcome
Enasidenib 30 mg
Participants received a single oral dose of enasidenib 30 mg on Day -3.
Enasidenib 50 mg
Participants received a single oral dose of enasidenib 50 mg on Day -3.
Enasidenib 75 mg
Participants received a single oral dose of enasidenib 75 mg on Day -3.
Enasidenib 100 mg
Participants received a single oral dose of enasidenib 100 mg on Day -3.
Enasidenib 150 mg
Participants received a single oral dose of enasidenib 150 mg on Day -3.
Enasidenib 200 mg
Participants received a single oral dose of enasidenib 200 mg on Day -3.
Enasidenib 300 mg
Participants received a single oral dose of enasidenib 300 mg on Day -3.
Enasidenib 450 mg
Participants received a single oral dose of enasidenib 450 mg on Day -3.
Enasidenib 650 mg
Participants received a single oral dose of enasidenib 650 mg on Day -3.
| Group | Source count |
|---|---|
| Enasidenib 30 mg | 3 |
| Enasidenib 50 mg | 7 |
| Enasidenib 75 mg | 7 |
| Enasidenib 100 mg | 56 |
| Enasidenib 150 mg | 8 |
| Enasidenib 200 mg | 10 |
| Enasidenib 300 mg | 4 |
| Enasidenib 450 mg | 1 |
| Enasidenib 650 mg | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enasidenib 30 mg | 2.43 | 1044.2 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg | -13.55 | 71.3 | Not reported | Not reported | Not reported |
| Enasidenib 75 mg | 9.32 | 862.2 | Not reported | Not reported | Not reported |
| Enasidenib 100 mg | -7.28 | 270.8 | Not reported | Not reported | Not reported |
| Enasidenib 150 mg | -16.61 | 127.7 | Not reported | Not reported | Not reported |
| Enasidenib 200 mg | -11.92 | 95.3 | Not reported | Not reported | Not reported |
| Enasidenib 300 mg | -17.79 | 92.0 | Not reported | Not reported | Not reported |
| Enasidenib 450 mg | -8.92 | NA | Not reported | Not reported | Could not be calculated when N = 1 |
| Enasidenib 650 mg | -16.14 | NA | Not reported | Not reported | Could not be calculated when N = 1 |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1044.2
- value
- 2.43
- group Id
- OG001
- spread
- 71.3
- value
- -13.55
- group Id
- OG002
- spread
- 862.2
- value
- 9.32
- group Id
- OG003
- spread
- 270.8
- value
- -7.28
- group Id
- OG004
- spread
- 127.7
- value
- -16.61
- group Id
- OG005
- spread
- 95.3
- value
- -11.92
- group Id
- OG006
- spread
- 92.0
- value
- -17.79
- comment
- Could not be calculated when N = 1
- group Id
- OG007
- spread
- NA
- value
- -8.92
- comment
- Could not be calculated when N = 1
- group Id
- OG008
- spread
- NA
- value
- -16.14
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 56
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- 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). Plasma 2-HG was measured using qualified LC-MS/MS in order to characterize the pharmacodynamic (PD) effects of enasidenib; the LLOQ was 30.0 ng/mL. Area under the effect concentration time curve from time point zero (predose) up to 10 hours postdose (AUEC0-10) was calculated using the linear trapezoid rule. Percent change from Baseline for AUEC0-10 was calculated as (AUEC0-10 minus \[Baseline\*Tlast\]) / (Baseline\*Tlast) \* 100, where Tlast corresponded to 10 hours and Baseline was equal to the average of the Screening and Day -3 (predose) 2-HG values. Data reported are the arithmetic mean and relative standard deviation expressed as a percentage.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received a single oral dose of enasidenib 30 mg on Day -3.
- id
- OG000
- title
- Enasidenib 30 mg
- description
- Participants received a single oral dose of enasidenib 50 mg on Day -3.
- id
- OG001
- title
- Enasidenib 50 mg
- description
- Participants received a single oral dose of enasidenib 75 mg on Day -3.
- id
- OG002
- title
- Enasidenib 75 mg
- description
- Participants received a single oral dose of enasidenib 100 mg on Day -3.
- id
- OG003
- title
- Enasidenib 100 mg
- description
- Participants received a single oral dose of enasidenib 150 mg on Day -3.
- id
- OG004
- title
- Enasidenib 150 mg
- description
- Participants received a single oral dose of enasidenib 200 mg on Day -3.
- id
- OG005
- title
- Enasidenib 200 mg
- description
- Participants received a single oral dose of enasidenib 300 mg on Day -3.
- id
- OG006
- title
- Enasidenib 300 mg
- description
- Participants received a single oral dose of enasidenib 450 mg on Day -3.
- id
- OG007
- title
- Enasidenib 450 mg
- description
- Participants received a single oral dose of enasidenib 650 mg on Day -3.
- id
- OG008
- title
- Enasidenib 650 mg
- param Type
- MEAN
- population Description
- Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PD parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
- reporting Status
- POSTED
- time Frame
- Screening visit, Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.
- title
- Phase 1: Percent Change From Baseline for Area Under the Effect Concentration Time Curve From Time 0 to 10 Hours Postdose (%BAUEC0-10) of 2-hydroxyglutarate (2-HG) on Day -3
- type
- SECONDARY
- unit Of Measure
- percent change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice