{"analyses":[{"ciLowerLimit":"0.79","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.34","estimateComment":"Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for dabrafenib were calculated.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Cmax of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Geometric Mean Ratio","paramValue":"1.03"},{"ciLowerLimit":"0.78","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.25","estimateComment":"Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2285403 were calculated.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Cmax of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Geometric Mean Ratio","paramValue":".99"},{"ciLowerLimit":"0.84","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.27","estimateComment":"Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2298683 were calculated.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Cmax of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Geometric Mean Ratio","paramValue":"1.03"},{"ciLowerLimit":"0.66","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.45","estimateComment":"Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2167542 were calculated.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Cmax of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Geometric Mean Ratio","paramValue":".98"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"379","upperLimit":"685","value":"509"},{"groupId":"OG001","lowerLimit":"390","upperLimit":"705","value":"524"}]}],"title":"GSK2118436"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"190","upperLimit":"352","value":"259"},{"groupId":"OG001","lowerLimit":"196","upperLimit":"331","value":"255"}]}],"title":"GSK2285403"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"595","upperLimit":"879","value":"724"},{"groupId":"OG001","lowerLimit":"587","upperLimit":"951","value":"747"}]}],"title":"GSK2298683"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.82","upperLimit":"14.5","value":"8.37"},{"groupId":"OG001","lowerLimit":"5.68","upperLimit":"11.7","value":"8.16"}]}],"title":"GSK2167542"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"description":"Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. From the plasma concentration-time curve, the PK parameter Cmax 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 a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.","id":"OG000","title":"Part A: Dabrafenib 75 mg"},{"description":"Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).","id":"OG001","title":"Part A: Dabrafenib 75 mg + Trametinib 2 mg"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Pharmacokinetic (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 15","title":"Part A: Maximum Plasma Concentration (Cmax) of a Single Dose of Dabrafenib Administered Alone and in Combination With Trametnib","type":"PRIMARY","unitOfMeasure":"Nanograms per milliliter (ng/mL)"}