TABLE 1

Summary of data used for population PK analysis and external model validationa

StudyStudy phaseNo. of subjectsNo. of PK samplesTafenoquine dose(s) studied (mg)FormulationPopulation by health status
200951 (DDI)124283300TabletHealthy volunteers
201780 (SIL)114232300TabletHealthy volunteers
TAF114582 (TQT)11552,215300, 600, 1,200CapsuleHealthy volunteers
TAF112582 (DETECTIVE part 1)2B2231,06750, 100, 300, 600CapsulePatients
TAF112582 (DETECTIVE part 2)32591,489300TabletPatients
TAF116564 (GATHER)31661,001300TabletPatients
  • a No. of subjects, the number of subjects from the tafenoquine-only arms that were included in the current analyses; DDI, drug-drug interaction study; SIL, stable isotope label study; TQT, thorough QTc study. The detailed sampling scheme is listed in Table S3 in the supplemental material.