{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9","value":"0.0923"},{"groupId":"OG001","spread":"32.9","value":"0.244"},{"groupId":"OG002","spread":"22.9","value":"0.402"},{"groupId":"OG003","spread":"34.1","value":"0.551"},{"groupId":"OG004","spread":"66.7","value":"1.43"},{"groupId":"OG005","spread":"54.1","value":"2.23"},{"groupId":"OG006","spread":"61.2","value":"2.17"},{"groupId":"OG007","spread":"78.6","value":"3.44"},{"groupId":"OG008","spread":"61.5","value":"1.09"},{"groupId":"OG009","spread":"27.9","value":"1.33"},{"groupId":"OG010","spread":"60.8","value":"2.12"},{"groupId":"OG011","spread":"46.4","value":"0.412"}]}],"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":"15"}],"units":"Participants"}],"title":"AUClast: 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21"},{"categories":[{"measurements":[{"groupId":"OG008","spread":"36.1","value":"4.39"},{"groupId":"OG009","spread":"48.7","value":"6.67"},{"groupId":"OG010","spread":"56.5","value":"9.09"},{"groupId":"OG011","spread":"69.9","value":"2.84"}]}],"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":"15"}],"units":"Participants"}],"title":"AUClast: Day 28"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9","value":"0.0923"},{"groupId":"OG001","spread":"32.9","value":"0.244"},{"groupId":"OG002","spread":"22.9","value":"0.402"},{"groupId":"OG003","spread":"34.1","value":"0.551"},{"groupId":"OG004","spread":"65.9","value":"1.42"},{"groupId":"OG005","spread":"54.1","value":"2.23"},{"groupId":"OG006","spread":"61.2","value":"2.17"},{"groupId":"OG007","spread":"78.6","value":"3.44"},{"groupId":"OG008","spread":"61.5","value":"1.09"},{"groupId":"OG009","spread":"27.9","value":"1.33"},{"groupId":"OG010","spread":"61.1","value":"2.12"},{"groupId":"OG011","spread":"46.4","value":"0.412"}]}],"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":"15"}],"units":"Participants"}],"title":"AUC0-24: Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"41.3","value":"1.02"},{"groupId":"OG001","spread":"56.3","value":"0.941"},{"groupId":"OG002","spread":"30.2","value":"1.78"},{"groupId":"OG003","spread":"32.0","value":"2.14"},{"groupId":"OG004","spread":"37.3","value":"4.80"},{"groupId":"OG005","spread":"27.1","value":"10.1"},{"groupId":"OG006","spread":"50.4","value":"8.37"},{"groupId":"OG007","spread":"54.6","value":"8.43"}]}],"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":"AUC0-24: Day 21"},{"categories":[{"measurements":[{"groupId":"OG008","spread":"36.1","value":"4.39"},{"groupId":"OG009","spread":"48.2","value":"6.65"},{"groupId":"OG010","spread":"56.2","value":"9.07"},{"groupId":"OG011","spread":"69.8","value":"2.83"}]}],"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":"15"}],"units":"Participants"}],"title":"AUC0-24: 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 (PK) assessments. Mean 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 120mg 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 270mg 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 (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 Parameter: Area Under the Concentration-time Curve to the Last Measurable Concentration (AUClast) and Area Under the Concentration-time Curve From Time Zero to 24 Hour (AUC0-24) of NMS-03592088","type":"SECONDARY","unitOfMeasure":"h·μM"}