Lack of effect of age and gender on MK-0767 pharmacokinetics in healthy subjects

Abstract

This analysis investigated the effect of age and gender on the pharmacokinetics (PK) of MK-0767, a dual PPARα/γ agonist, in healthy men and women. Sixteen healthy elderly men and women received single doses of 10 mg MK-0767 (n=12; 6 males, 6 females) or placebo (n=4). Once it was established that there were no clinically important PK differences between elderly women and men, the elderly subjects (n=12; mean age 72 yr; range 65 to 82) were pooled across genders to compare PK in elderly versus historical data in young men (n=12; mean age 31.7 yr; range 22 to 43). Overall, the single-dose PK of MK-0767 in elderly women and men were similar with respect to AUC(0-∞), Cmax, Tmax and apparent t1/2. The AUC(0∞) GMR for elderly women/elderly men was 1.11 with a 90% CI of (0.93, 1.32). In addition, the single-dose PK of MK-0767 were similar in the elderly (pooled across genders) and young men with respect to AUC(0-∞), Cmax, Tmax, and apparent t1/2. The AUC(0-∞) GMR for pooled elderly/young was 1.04 with a 90% CI of (0.94, 1.14). A single oral dose of 10 mg of MK-0767 was generally well tolerated in healthy elderly. Based on this initial assessment, the single-dose PK of MK-0767 are generally similar in elderly men and women, and also similar between healthy elderly and young men. These findings are particularly important because the primary disease target population for MK-0767, patients with type 2 diabetes, comprise a significant number of elderly men and women. Clinical Pharmacology & Therapeutics (2004) 75, P58–P58; doi: 10.1016/j.clpt.2003.11.219