{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"32.5","value":"844"},{"groupId":"OG001","spread":"39.7","value":"2030"},{"groupId":"OG002","spread":"31.3","value":"1940"},{"groupId":"OG003","spread":"50.9","value":"2680"},{"groupId":"OG004","spread":"31.0","value":"1630"},{"groupId":"OG005","spread":"17.5","value":"1070"},{"groupId":"OG006","spread":"36.0","value":"1770"},{"groupId":"OG007","spread":"0","value":"1070"}]}],"title":"V/F: Day 21"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.8","value":"4880"},{"groupId":"OG001","spread":"20.3","value":"9440"},{"groupId":"OG002","spread":"22.8","value":"8800"},{"groupId":"OG003","spread":"39.4","value":"10900"},{"groupId":"OG004","spread":"25.8","value":"5810"},{"groupId":"OG005","spread":"37.0","value":"4710"},{"groupId":"OG006","spread":"37.0","value":"8270"},{"groupId":"OG007","spread":"0","value":"10500"}]}],"title":"Vss/F: Day 21"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"}],"units":"Participants"}],"description":"Plasma samples were collected and used for pharmacokinetics (PK) assessments.\n\nMean values of PK parameters are presented with the coefficient of variation (CV%)","dispersionType":"Standard Deviation","groups":[{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.","id":"OG000","title":"Phase 1, Schedule A: 20 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG001","title":"Phase 1, Schedule A: 40 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG002","title":"Phase 1, Schedule A: 80 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG003","title":"Phase 1, Schedule A: 120 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG004","title":"Phase 1, Schedule A: 180 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG005","title":"Phase 1, Schedule A: 270 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG006","title":"Phase 1, Schedule A: 300 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG007","title":"Phase 1, Schedule A: 360 mg"},{"description":"All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle","id":"OG008","title":"Phase 1, Schedule B: 120 mg"},{"description":"All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.","id":"OG009","title":"Phase 1, Schedule B: 180 mg"},{"description":"All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle","id":"OG010","title":"Phase 1, Schedule B: 250 mg"},{"description":"Participants who had failed standard of care including Venetoclax and Gilteritining based therapies.\n\nNMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards","id":"OG011","title":"Phase 2, Schedule B:360+150 mg"}],"paramType":"MEAN","populationDescription":"Participants evaluable for PK analysis (participants with sufficient samples to provide interpretable results). The plasma PK of NMS-03592088 and NMS-03593860 and NMS-03603422 were collected for PK profile.\n\nThe half-life of the molecule was many times longer than 24 hours, so it was not possible to estimate it at all for Schedule B due to the 24-hour sampling. Therefore, parameters V/F, Vss/F could not be calculated.","reportingStatus":"POSTED","timeFrame":"Schedule A: Day 21","title":"Pharmacokinetic Parameters: Apparent Volume of Distribution (V/F) and Apparent Volume of Distribution at Steady State (Vss/F)","type":"SECONDARY","unitOfMeasure":"L"}