{"analyses":[{"ciLowerLimit":"1.10","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"2.08","estimateComment":"Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.","groupIds":["OG001","OG003"],"nonInferiorityComment":"Following loge tranformation, Cmax of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Geometric Mean Ratio","paramValue":"1.51"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"914","upperLimit":"1365","value":"1117"},{"groupId":"OG001","lowerLimit":"1059","upperLimit":"2631","value":"1669"},{"groupId":"OG002","lowerLimit":"924","upperLimit":"1764","value":"1227"},{"groupId":"OG003","lowerLimit":"1622","upperLimit":"3231","value":"2289"}]}],"title":"Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"811","upperLimit":"1358","value":"1050"},{"groupId":"OG001","lowerLimit":"1344","upperLimit":"2269","value":"1746"},{"groupId":"OG002","lowerLimit":"895","upperLimit":"1654","value":"1217"},{"groupId":"OG003","lowerLimit":"1472","upperLimit":"2860","value":"2052"}]}],"title":"Day 21"}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"}],"units":"Participants"}],"description":"The PK parameter Cmax was assessed. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.","id":"OG000","title":"Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg"},{"description":"Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.","id":"OG001","title":"Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg"},{"description":"Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.","id":"OG002","title":"Part D: Dabrafenib 75 mg + Trametinib 2 mg"},{"description":"Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.","id":"OG003","title":"Part D: Dabrafenib 150 mg + Trametinib 2 mg"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK Population: all participants who received at least one dose of either dabrafenib or trametinib and for whom a PK sample was obtained and analyzed","reportingStatus":"POSTED","timeFrame":"Day 1 and Day 21","title":"Part D (Analyte=GSK2118436): Maximum Plasma Concentration (Cmax) of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib","type":"PRIMARY","unitOfMeasure":"ng/mL"}