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Purpose of the study VCH-286 is being developed as a novel drug for the treatment of human immunodeficiency virus (HIV). VCH-286 (IC90 HIV-1Ba-L ~0.21 nM) targets the chemokine coreceptor CCR5 on the cell surface and specifically blocks the entry of CCR5-tropic strains of HIV-1 into host cells. The primary objective of the study was to evaluate the safety/tolerability of VCH-286 following oral administration of single ascending doses (from 25 to 800 mg) in healthy subjects. The secondary objectives were; 1) to determine the pharmacokinetic (PK) profile of VCH-286 under fasting conditions; 2) to evaluate the effect of food on the exposure of 400 mg VCH-286; and 3) to evaluate the effect of 100 mg ritonavir on the exposure 25 mg VCH-286 under fasting conditions.

Results of a Phase I study to evaluate the safety, tolerability, pharmacokinetics (with and without ritonavir) and food-effect of VCH-286