A Multidose Study to Examine the Effect of Food on Evacetrapib Exposure at Steady State

Journal of Cardiovascular Pharmacology and Therapeutics
David S SmallJeffrey G Suico

Abstract

To determine the effect of a high-fat meal on evacetrapib exposure at steady state in healthy participants. This was a randomized, 2-period, 2-sequence, open-label, crossover study. Patients were randomly assigned to 1 of the 2 treatment sequences in which they received evacetrapib 130 mg/d for 10 days following a 10-hour fast each day or following a high-fat breakfast each day. Plasma samples collected through 24 hours were analyzed for evacetrapib concentrations and pharmacokinetic parameter estimates including area under the concentration-time curve during a dosing interval (AUCτ), maximum observed concentration (Cmax), and time of Cmax (tmax) were calculated. Pharmacodynamic parameters, including cholesteryl ester transfer protein (CETP) activity, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol, and triglycerides, were also assessed. A total of 34 males and 6 females, mean age 41.5 years and mean body mass index 26.6 kg/m(2), were enrolled. Statistical analysis showed AUCτ was 44% higher (90% confidence interval [CI]: 29%-62%) and Cmax was 51% higher (90% CI: 28%-79%) in the fed state than in the fasted state, indicating an effect of food. Consistent with higher e...Continue Reading

References

Feb 24, 2001·Statistical Methods in Medical Research·B SpiessensD L DeMets

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Citations

Feb 10, 2016·European Journal of Clinical Pharmacology·David S SmallJeffrey G Suico
Jun 15, 2017·Circulation. Cardiovascular Quality and Outcomes·Spencer Phillips HeyAaron S Kesselheim

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Clinical Trials Mentioned

NCT01810432
NCT01105975

Software Mentioned

WinNonlin

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