Comparison of MK‐0767 pharmacokinetics in Japanese and non‐Japanese subjects

An analysis was performed to compare preliminary pharmacokinetics (PK) of MK‐0767, a dual PPARα/γ agonist, between Japanese and non‐Japanese populations after single and multiple oral doses of MK‐0767. The PK data from available MK‐0767 Phase I studies in a non‐Japanese population (5 studies) were pooled (single dose and multiple dose studies separately) and compared to that from Phase I studies in a Japanese population (2 studies). The analysis included single doses from 1‐ to 10‐mg and multiple doses from 0.3‐ to 25–mg at steady state; all subjects included in this analysis were young healthy male volunteers. An analysis of covariance (ANCOVA) model was used with a factor for population and covariates age, weight, height, and log transformed dose level. To assess the magnitude of the difference between the two populations with respect to AUC and C max , the geometric mean ratio (GMR) (Japanese/non‐Japanese) with 90% confidence intervals (CIs) were provided based on the above ANCOVA model. Following single doses, the dose‐adjusted AUC (0‐∞) GMR was 0.89 with a 90% CI of (0.78, 1.02) and the dose‐adjusted C max GMR was 1.00 with a 90% CI of (0.89, 1.12). Following multiple doses at steady state, the dose‐adjusted AUC (0‐24hr) GMR was 1.18 with a 90% CI of (0.99, 1.40) and the dose‐adjusted C max GMR was 1.13 with a 90% CI of (0.95, 1.33). Based on this analysis, pharmacokinetics of MK‐0767 are similar in Japanese and non‐Japanese subjects. Clinical Pharmacology & Therapeutics (2004) 75 , P11–P11; doi: 10.1016/j.clpt.2003.11.040