{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"72.1","value":"8987"},{"groupId":"OG001","spread":"59.6","value":"9611"},{"groupId":"OG002","spread":"50.6","value":"17330"},{"groupId":"OG003","spread":"55.6","value":"21656"},{"groupId":"OG004","spread":"29.6","value":"28989"},{"groupId":"OG005","spread":"48.3","value":"37703"},{"groupId":"OG006","spread":"41.5","value":"58743"},{"comment":"Percent coefficient of variation could not be calculated due to small sample size","groupId":"OG007","spread":"NA","value":"60846"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"56"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"11"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"0"}],"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 enasidenib 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 24 hours post-dose (AUC0-24) was calculated using the linear trapezoidal rule.","dispersionType":"Geometric Coefficient of Variation","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"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK 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.","reportingStatus":"POSTED","timeFrame":"Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours post-dose.","title":"Phase 1: Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Enasidenib After a Single Oral Dose on Day -3","type":"SECONDARY","unitOfMeasure":"ng*h/mL"}