rocacetrapib (CKD-519) / Chong Kun Dang - LARVOL DELTA

A Population Pharmacokinetic and Pharmacodynamic Model of CKD-519. (PubMed, Pharmaceutics) - "After the PK model development, the CETP activity and cholesterol (HDL-C and LDL-C) levels were sequentially modeled using the turnover model, including the placebo effect. According to PK-PD simulation results, 200 to 400 mg of CKD-519 showing a 40% change in HDL-C and LDL-C from baselines was recommended for proof of concept studies in patients with dyslipidemia."

Clinical • Journal • PK/PD data • Chronic Kidney Disease • Dyslipidemia

Quantitative Prediction of Human Pharmacokinetics and Pharmacodynamics of CKD519, a Potent Inhibitor of Cholesteryl Ester Transfer Protein (CETP). (PubMed, Pharmaceutics) - "However, there were some discrepancies between the predicted and observed human PK/PD profiles compared to the phase I clinical data. The huge difference between the observed and predicted bioavailability suggests that there is a hurdle in predicting the absorption parameter only from animal PK data."

Journal • PK/PD data