{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"43","value":"1650"},{"groupId":"OG001","spread":"64","value":"1990"},{"groupId":"OG002","spread":"53","value":"3190"},{"groupId":"OG003","spread":"51","value":"4830"},{"groupId":"OG004","spread":"46","value":"3490"},{"groupId":"OG005","spread":"56.8","value":"2370"},{"groupId":"OG006","spread":"49.4","value":"1510"}]}],"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":"32"},{"groupId":"OG006","value":"14"}],"units":"Participants"}],"title":"Cedazuridine"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20","value":"503"},{"groupId":"OG001","spread":"64","value":"917"},{"groupId":"OG002","spread":"48","value":"1670"},{"groupId":"OG003","spread":"34","value":"2180"},{"groupId":"OG004","spread":"56","value":"1560"},{"groupId":"OG005","spread":"48.3","value":"1190"},{"groupId":"OG006","spread":"38","value":"710"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"12"},{"groupId":"OG005","value":"37"},{"groupId":"OG006","value":"19"}],"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":"37"},{"groupId":"OG006","value":"19"}],"units":"Participants"}],"description":"AUC is a measure of the plasma concentration of the drug over time (AUC0-8). PK parameters are reported for the dose escalation stage by cohort in Phase 1 and dose confirmation and fixed-dose combination stages in Phase 2.","dispersionType":"Geometric Coefficient of Variation","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":"GEOMETRIC_MEAN","populationDescription":"Participants with evaluable PK measurements are included.","reportingStatus":"POSTED","timeFrame":"At specified timepoints from 0 to 24 hours post-dose","title":"Area Under the Concentration Versus Time Curve of Cedazuridine (E7727) and Cedazuridine-epimer","type":"SECONDARY","unitOfMeasure":"ng*h/mL"}