Cenicriviroc versus Simvastatin
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Study Design
This was a phase 1, 3 period fixed-sequence study with n=12 healthy subjects evaluating the effect of cenicriviroc (CVC) dosed at 150mg QD for 10 days on the PK, safety and tolerability of simvastatin. Subjects received 20mg of simvastatin on day 1 then CVC alone for 10 days which is started on day 2 or 3 based on simvastatin half-life and then CVC with simvastatin on the last day of the study. Plasma concentrations were collected over 24-48 hours post-dose for simvastatin with or without CVC administration. Other PK parameters were determined using non-compartmental methods. Geometric least squares ratios and confidence intervals were estimated.
Study Results
Based on GMRs and 90% confidence intervals, there was a 148% increase in AUC (2.14, 2.88) and a 160% increase in Cmax (2.14, 3.16) of simvastatin. PK parameters for CVC were not reported.
Study Conclusions
This combination was generally well tolerated, with no adverse events leading to treatment discontinuation. Per the authors, the interaction of CVC with simvastatin suggests that a dosage adjustment may be warranted when co-administered.
References
Lefebvre, Harris. Effect of cenicriviroc on the pharmacokinetics and safety of hmg-coa reductase inhibitors (simvastatin, simvastatin and rosuvastatin) in healthy subjects . Aasld: American Association Of The Study Of Liver Diseases. Boston, MA, USA. 2016; November .
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