Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose ritonavir in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
AUCτ (area under the concentration time curve of BILR 355 in plasma over one dosing interval at steady state)
Time frame: up to day 11
Cmax (maximum concentration of BILR 355 in plasma)
Time frame: up to day 11
Time for BILR 355 BS to achieve steady state
Time frame: up to day 11
Cmin,ss (trough concentration of BILR 355 BS in plasma at steady state)
Time frame: up to day 11
Incidence of dose limiting toxicity
Time frame: up to day 21
tmax (time from dosing to the maximum concentration of BILR 355 in plasma)
Time frame: up to day 11
AUCτ (area under the concentration time curve of metabolite 402 in plasma over one dosing interval at steady state)
Time frame: up to day 11
Cmax (maximum concentration of metabolite 402 in plasma)
Time frame: up to day 11
Ae (amount of BILR 355 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)
Time frame: up to day 11
Metabolite BILR 402 Ae (amount of BILR 402 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)
Time frame: up to day 11
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Number of subjects with adverse events
Time frame: up to 42 days