{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2","upperLimit":"4","value":"3"},{"groupId":"OG001","lowerLimit":"2","upperLimit":"4","value":"3"},{"groupId":"OG002","lowerLimit":"3","upperLimit":"4","value":"3"},{"groupId":"OG003","lowerLimit":"2","upperLimit":"6","value":"3"},{"groupId":"OG004","lowerLimit":"2","upperLimit":"6","value":"3"},{"groupId":"OG005","lowerLimit":"1.50","upperLimit":"4.08","value":"3"},{"groupId":"OG006","lowerLimit":"2.00","upperLimit":"7.18","value":"3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"19"},{"groupId":"OG005","value":"47"},{"groupId":"OG006","value":"29"}],"units":"Participants"}],"title":"Cedazuridine"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2","upperLimit":"4","value":"3"},{"groupId":"OG001","lowerLimit":"2","upperLimit":"3","value":"3"},{"groupId":"OG002","lowerLimit":"3","upperLimit":"4","value":"3"},{"groupId":"OG003","lowerLimit":"2","upperLimit":"6","value":"3"},{"groupId":"OG004","lowerLimit":"2","upperLimit":"6","value":"3"},{"groupId":"OG005","lowerLimit":"1.50","upperLimit":"6.17","value":"3"},{"groupId":"OG006","lowerLimit":"2.00","upperLimit":"7.20","value":"3.05"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"19"},{"groupId":"OG005","value":"47"},{"groupId":"OG006","value":"29"}],"units":"Participants"}],"title":"Cedazuridine-epimer"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"19"},{"groupId":"OG005","value":"47"},{"groupId":"OG006","value":"30"}],"units":"Participants"}],"description":"Tmax is the time to maximum observed plasma concentration. PK parameters are reported for the dose escalation stage by cohort in Phase 1 and the dose confirmation and fixed-dose combination stages in Phase 2.","dispersionType":"Full Range","groups":[{"description":"Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).","id":"OG000","title":"Phase 1 Dose Escalation Cohort 1"},{"description":"Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).","id":"OG001","title":"Phase 1 Dose Escalation Cohort 2"},{"description":"Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).","id":"OG002","title":"Phase 1 Dose Escalation Cohort 3"},{"description":"Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).","id":"OG003","title":"Phase 1 Dose Escalation Cohort 4"},{"description":"Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).","id":"OG004","title":"Phase 1 Dose Escalation Cohort 5"},{"description":"Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.","id":"OG005","title":"Phase 2 Dose Confirmation"},{"description":"Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.","id":"OG006","title":"Phase 2 Fixed-Dose Combination"}],"paramType":"MEDIAN","populationDescription":"Participants with evaluable PK measurements are included.","reportingStatus":"POSTED","timeFrame":"At specific timepoints from 0 to 24 hours post-dose","title":"Time to Maximum Observed Plasma Concentration (Tmax) of Cedazuridine (E7727) and Cedazuridine-epimer","type":"SECONDARY","unitOfMeasure":"hours"}