{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.9","value":"0.00469"},{"groupId":"OG001","spread":"19.1","value":"0.0174"},{"groupId":"OG002","spread":"33.6","value":"0.0262"},{"groupId":"OG003","spread":"53.1","value":"0.0388"},{"groupId":"OG004","spread":"43.9","value":"0.118"},{"groupId":"OG005","spread":"84.2","value":"0.211"},{"groupId":"OG006","spread":"55.5","value":"0.207"},{"groupId":"OG007","spread":"79.8","value":"0.240"},{"groupId":"OG008","spread":"82.4","value":"0.0907"},{"groupId":"OG009","spread":"42.9","value":"0.124"},{"groupId":"OG010","spread":"51.1","value":"0.183"},{"groupId":"OG011","spread":"43.9","value":"0.0995"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"3"}],"units":"Participants"}],"title":"Cmax: Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"52.5","value":"0.0523"},{"groupId":"OG001","spread":"32.4","value":"0.0526"},{"groupId":"OG002","spread":"22.6","value":"0.0896"},{"groupId":"OG003","spread":"45.9","value":"0.125"},{"groupId":"OG004","spread":"64.0","value":"0.320"},{"groupId":"OG005","spread":"41.9","value":"0.553"},{"groupId":"OG006","spread":"50.6","value":"0.444"},{"groupId":"OG007","spread":"40.9","value":"0.467"}]}],"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"}],"title":"Cmax: Day 21"},{"categories":[{"measurements":[{"groupId":"OG008","spread":"42.0","value":"0.266"},{"groupId":"OG009","spread":"46.5","value":"0.354"},{"groupId":"OG010","spread":"54.4","value":"0.462"},{"groupId":"OG011","spread":"37.7","value":"0.168"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"3"}],"units":"Participants"}],"title":"Cmax: Day 28"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"38.2","value":"0.00363"},{"groupId":"OG001","spread":"55.5","value":"0.00819"},{"groupId":"OG002","spread":"19.0","value":"0.0132"},{"groupId":"OG003","spread":"45.7","value":"0.0188"},{"groupId":"OG004","spread":"52.3","value":"0.0309"},{"groupId":"OG005","spread":"46.5","value":"0.0568"},{"groupId":"OG006","spread":"68.8","value":"0.137"},{"groupId":"OG007","spread":"75.7","value":"0.0930"},{"groupId":"OG008","spread":"37.2","value":"0.0296"},{"groupId":"OG009","spread":"79.4","value":"0.0536"},{"groupId":"OG010","spread":"19.7","value":"0.0957"},{"groupId":"OG011","spread":"43.6","value":"0.0816"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"3"}],"units":"Participants"}],"title":"Clast: Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"59.7","value":"0.0151"},{"groupId":"OG001","spread":"102","value":"0.00902"},{"groupId":"OG002","spread":"77.2","value":"0.0199"},{"groupId":"OG003","spread":"81.4","value":"0.0230"},{"groupId":"OG004","spread":"48.7","value":"0.0548"},{"groupId":"OG005","spread":"20.1","value":"0.0876"},{"groupId":"OG006","spread":"86.9","value":"0.0831"},{"groupId":"OG007","spread":"80.9","value":"0.215"}]}],"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"}],"title":"Clast: Day 21"},{"categories":[{"measurements":[{"groupId":"OG008","spread":"39.5","value":"0.141"},{"groupId":"OG009","spread":"53.1","value":"0.293"},{"groupId":"OG010","spread":"53.3","value":"0.322"},{"groupId":"OG011","spread":"20.3","value":"0.116"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"3"}],"units":"Participants"}],"title":"Clast: Day 28"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9","value":"0.00385"},{"groupId":"OG001","spread":"32.9","value":"0.0102"},{"groupId":"OG002","spread":"22.9","value":"0.0168"},{"groupId":"OG003","spread":"34.1","value":"0.0230"},{"groupId":"OG004","spread":"65.9","value":"0.0591"},{"groupId":"OG005","spread":"54.1","value":"0.0931"},{"groupId":"OG006","spread":"61.2","value":"0.0905"},{"groupId":"OG007","spread":"78.6","value":"0.143"},{"groupId":"OG008","spread":"61.5","value":"0.0455"},{"groupId":"OG009","spread":"27.9","value":"0.0554"},{"groupId":"OG010","spread":"61.1","value":"0.0883"},{"groupId":"OG011","spread":"46.4","value":"0.0172"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"3"}],"units":"Participants"}],"title":"Cavg: Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"41.3","value":"0.0423"},{"groupId":"OG001","spread":"56.3","value":"0.0392"},{"groupId":"OG002","spread":"30.2","value":"0.0740"},{"groupId":"OG003","spread":"32.0","value":"0.0890"},{"groupId":"OG004","spread":"37.3","value":"0.200"},{"groupId":"OG005","spread":"27.1","value":"0.421"},{"groupId":"OG006","spread":"50.4","value":"0.349"},{"groupId":"OG007","spread":"54.6","value":"0.351"}]}],"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":"9"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"}],"units":"Participants"}],"title":"Cavg: Day 21"},{"categories":[{"measurements":[{"groupId":"OG008","spread":"36.1","value":"0.183"},{"groupId":"OG009","spread":"48.2","value":"0.277"},{"groupId":"OG010","spread":"56.2","value":"0.378"},{"groupId":"OG011","spread":"69.8","value":"0.118"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"3"}],"units":"Participants"}],"title":"Cavg: Day 28"}],"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":"4"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"15"}],"units":"Participants"}],"description":"Plasma samples were collected and used for pharmacokinetics 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. NMS-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 (treated participants were considered evaluable if they had sufficient baseline and on-study sampled material to provide interpretable results). The plasma PK of NMS-03592088 and 2 metabolites NMS-03593860 and NMS-03603422 were collected, and PK profile characterised.\n\nSchedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28","reportingStatus":"POSTED","timeFrame":"Schedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28","title":"Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax), Last Measurable Concentration (Clast), and Average Concentration (Cavg) of NMS-03592088","type":"SECONDARY","unitOfMeasure":"μM"}