{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.73","value":"9.71"},{"groupId":"OG001","spread":"2.13","value":"7.67"},{"groupId":"OG002","spread":"1.38","value":"7.76"},{"groupId":"OG003","spread":"1.88","value":"6.53"},{"groupId":"OG004","spread":"3.04","value":"7.91"},{"groupId":"OG005","spread":"2.18","value":"7.49"},{"groupId":"OG006","spread":"2.22","value":"8.61"},{"groupId":"OG007","spread":"2.80","value":"12.7"},{"groupId":"OG008","spread":"2.60","value":"8.87"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"11"},{"groupId":"OG005","value":"13"},{"groupId":"OG006","value":"31"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"49"}],"units":"Participants"}],"description":"Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.\n\nBlood samples for CL/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state.","id":"OG000","title":"10 mg QD Dose Escalation Cohort"},{"description":"Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state.","id":"OG001","title":"20 mg QD Dose Escalation Cohort"},{"description":"Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state..","id":"OG002","title":"40 mg QD Dose Escalation Cohort"},{"description":"Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.","id":"OG003","title":"20 mg BID Dose Escalation Cohort"},{"description":"Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.","id":"OG004","title":"80 mg QD Dose Escalation Cohort"},{"description":"Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.","id":"OG005","title":"40 mg BID Dose Escalation Cohort"},{"description":"Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state.","id":"OG006","title":"120 mg QD Dose Escalation Cohort"},{"description":"Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state.","id":"OG007","title":"160 mg QD Dose Escalation Cohort"},{"description":"Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.","id":"OG008","title":"80 mg QD Expansion Cohort"}],"paramType":"MEAN","populationDescription":"All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.","reportingStatus":"POSTED","timeFrame":"cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position","title":"Apparent Total Body Clearance (CL/F) of MK-8628/OTX015","type":"SECONDARY","unitOfMeasure":"L/hour"}