{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.00","upperLimit":"70.42","value":"36.38"},{"groupId":"OG001","lowerLimit":"1.92","upperLimit":"69.50","value":"10.00"},{"groupId":"OG002","lowerLimit":"3.00","upperLimit":"71.00","value":"10.00"},{"groupId":"OG003","lowerLimit":"3.00","upperLimit":"74.42","value":"48.00"},{"groupId":"OG004","lowerLimit":"6.20","upperLimit":"72.10","value":"24.12"},{"groupId":"OG005","lowerLimit":"1.98","upperLimit":"72.82","value":"47.33"},{"groupId":"OG006","lowerLimit":"7.95","upperLimit":"72.17","value":"48.10"},{"groupId":"OG007","lowerLimit":"48.25","upperLimit":"71.50","value":"59.88"},{"groupId":"OG008","lowerLimit":"6.17","upperLimit":"6.17","value":"6.17"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"55"},{"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). 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.","dispersionType":"Full Range","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":"MEDIAN","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: Time to Maximum Concentration (Tmax) of AGI-16903 After a Single Oral Dose of Enasidenib on Day -3","type":"SECONDARY","unitOfMeasure":"hours"}