Fig 1.
Clinical trial design describing the three different treatment sequences and the wash-out period.
Fig 2.
Dosing scheme for the 3 treatment arms with the corresponding weight based exposure for the body weight range of the subjects included in the study.
Fixed-dose 18 mg and 36mg with 18 mg tablets and 200μg/kg with 6mg tablets.
Table 1.
Baseline characteristics of study population (n = 57) in the 3 weight strata.
BMI: body mass index.
Fig 3.
Group 1, subjects weighing from 51 to 65 kg, Group 2 weighing from 66 to 79 kg and Group 3 weighing ≥ 80 kg.
Flow diagram of the study.
Table 2.
Distribution of adverse events by frequency and treatment arm.
WA-ref: weight adjusted reference group (200 μg/kg), FD18: fixed-dose 18 mg, FD36: fixed-dose 36 mg).
Table 3.
Distribution of adverse events by treatment arm.
WA-ref: weight adjusted reference group (200 μg/Kg), FD18: fixed-dose 18 mg, FD36: fixed-dose 36 mg).
Fig 4.
Mean IVM plasma concentration profiles in 54 individuals exposed sequentially in random order to the 3 treatment arms.
Insert describe details of the time points within the initial 36 hours. WA-ref: weight adjusted reference group (200 μg/kg), FD18: fixed-dose 18 mg, FD36: fixed-dose 36 mg).
Table 4.
PK parameters of IVM for entire study population and by the 3 weight strata.
WA-ref: weight adjunted reference group (200 μg/kg), FD18: fixed-dose 18 mg, FD36: fixed-dose 36 mg).
Table 5.
Effect of BMI and weight in PK parameters.