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Articles

Effect of age and gender on the safety, tolerability, and pharmacokinetics of BAY 12-9566 in healthy subjects

C Lathia, A Shah, and P Sundaresan

The impact of age and gender on the single-dose pharmacokinetics, safety, and tolerability of BAY 12-9566 was evaluated in healthy subjects. Volunteers were grouped according to age and gender (13 young males, 11 elderly males, and 12 elderly females) and then randomized in a 2:1 ratio to receive a single oral 50 mg dose of BAY 12-9566 or placebo. Serial plasma samples were collected up to 336 hours postdose and assayed for BAY 12-9566. Peak plasma concentration, time to reach peak plasma concentration, the area under the concentration-time curve, oral clearance, volume of distribution, and elimination half-life were calculated. BAY 12-9566 was well tolerated in all treatment groups, and no serious adverse events occurred during the study. Substantial age- or gender-related differences were not observed for any of the pharmacokinetic parameters tested. Based on these pharmacokinetic and tolerability profiles, age- or gender-related dose adjustments were not required for BAY 12-9566.
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