This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate the effect of food on the pharmacokinetics of a single oral dose of AVL-292.
Part 2 is an open-label, randomized, 2-period, 2-way crossover study to evaluate the effect of a standard high-fat breakfast on the pharmacokinetics of AVL-292. Ten subjects will be enrolled to receive 2 single doses of 200 mg AVL-292, one with food (i.e., fed) and the other without (i.e., fasted), in a randomized sequence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
54
Covance Clinical Research Unit
Dallas, Texas, United States
Adverse Events
Number of participants with adverse events
Time frame: Up to 28 days after last AVL-292 dose
PK-(Cmax)
Maximum observed concentration in plasma
Time frame: 24 hours after the last AVL-292 dose on days 1 and 7
PK-(AUC)
Area under the plasma concentration-time curve
Time frame: 24 hours after the last AVL-292 dose days 1 and 7
Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells
Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells
Time frame: 24 hours after the last AVL-292 dose days 1 and 7
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