J. Lipid Res.
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A more recent version of this article appeared on June 1, 2008

Papers In Press, published online ahead of print March 6, 2008
J. Lipid Res., doi:10.1194/jlr.P800003-JLR200
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Submitted on January 16, 2008
Revised on March 6, 2008
Accepted on March 6, 2008

Safety, pharmacokinetics and pharmacodynamics of a single dose of oral apolipoprotein A-I mimetic peptide D-4F in high-risk cardiovascular patients

LeAnne Bloedon, Richard Dunbar, Danielle Duffy, Paula Pinell-Salles, Robert Norris, Bruce J. DeGroot, Rajesh Movva, Mohamad Navab, Alan M. Fogelman, and Daniel J. Rader

Medicine, Univ Penn, Philadelphia, PA 19104-6160

Corresponding Author: rader{at}mail.med.upenn.edu

Patients with coronary heart disease or equivalent risk received a single dose of 30, 100, 300, or 500 mg of unformulated D-4F (n=8, each dose) or placebo (n=8) under fasting conditions. An additional 10 patients received 500 mg (n=8) or placebo (n=2) with a low fat meal. There were no significant trends in any safety parameter. D-4F was detectable in plasma at all doses with a Tmax of 30 min, 1 hr, and 2 hr for 30, 100, and  300 mg, respectively. The AUC(0-t) was 27.81 ng*hr/mL and 54.71 ng*hr/mL for the 300 and 500 mg dose groups, respectively and 17.96 ng*hr/mL for the 500 mg dose given with food. The HDL anti-inflammatory index significantly improved at 4 hours at the 300 mg dose and 2 hr at the 500 mg dose compared to placebo (p<0.05). There were no changes in plasma lipid or lipoprotein levels. We conclude that unformulated D-4F has low bioavailability that is improved under fasting conditions, and that a single dose of D-4F is safe and well tolerated, and may improve the HDL anti-inflammatory index.


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B. J. Van Lenten, A. C. Wagner, C.-L. Jung, P. Ruchala, A. J. Waring, R. I. Lehrer, A. D. Watson, S. Hama, M. Navab, G. M. Anantharamaiah, et al.
Anti-inflammatory apoA-I-mimetic peptides bind oxidized lipids with much higher affinity than human apoA-I
J. Lipid Res., November 1, 2008; 49(11): 2302 - 2311.
[Abstract] [Full Text] [PDF]


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