The Phase 1b/2a trial was a double blind safety and tolerance study which investigated the pharmacokinetics and also early pharmacodynamics effects of RVX-208. A total of 72 subjects enrolled in the trial. The study had three arms, a low dose arm with 24 subjects, a dose-escalation arm with 24 subjects, and a third high dose arm with 24 subjects. This trial also examined early markers for reverse cholesterol transport such as ApoA-l, HDL-c, pre-beta HDL and alpha HDL subparticles. Approximately half of the subjects had low levels of baseline HDL cholesterol.
Highlights from the study are as follows:
- The primary endpoint, plasma ApoA-I increase compared to placebo, achieved a range in all subjects of 5.1% - 10.4% in all doses at days 8 and 28 respectively. - At the lowest dose of 1mg/kg b.i.d. in subjects with low levels of HDL-c, plasma ApoA-l increases reached statistical significance of 5.7% (p(less than)0.05) at day 8 and 7.8% (p(less than)0.05) at day 28. - A critical RCT functionality marker, alpha-1 HDL particles, illustrated highly statistical significance with an increase of 46.7% (p(less than)0.004), in all subjects and 57.2% (p(less than)0.02) in the low dose arm over placebo at day 28. - Pharmacokinetic parameters of RVX-208 were dose dependant with oral administration. - RVX-208 was shown to be compatible with simvastatin (40mg). - Seventy out of seventy two subjects completed the tria
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