{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"105.1","value":"17575"},{"groupId":"OG001","spread":"68.6","value":"19975"},{"groupId":"OG002","spread":"51.9","value":"39345"},{"groupId":"OG003","spread":"74.2","value":"53018"},{"groupId":"OG004","spread":"31.2","value":"76820"},{"groupId":"OG005","spread":"50.5","value":"95959"},{"groupId":"OG006","spread":"32.6","value":"134094"},{"comment":"Percent coefficient of variation could not be calculated due to small sample size","groupId":"OG007","spread":"NA","value":"157042"},{"comment":"Percent coefficient of variation could not be calculated due to small sample size","groupId":"OG008","spread":"NA","value":"38711"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"58"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"11"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"2"},{"groupId":"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 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 the time of the last quantifiable concentration (AUC0-t) 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, 24, 48, and 72 hours post-dose.","title":"Phase 1: Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Enasidenib After a Single Oral Dose on Day -3","type":"SECONDARY","unitOfMeasure":"ng*h/mL"}