Effect of food and gender on the pharmacokinetics of tucaresol in healthy volunteers

Aims The potential effects of food and gender on the pharmacokinetics of tucaresol were investigated in healthy volunteers. Methods Ten males (mean weight 76.5 kg, age 27-42 years) and eight females (mean weight 58.9 kg, age 18-44 years) received a single oral dose of 200 mg tucaresol on two occasions in random order. On one occasion, tucaresol was given after an overnight fast and on the other, immediately after ingestion of a standard breakfast. Results There were no significant differences in standard pharmacokinetic parameters between the two occasions but the rate of tucaresol absorption was faster after food intake. Female subjects had higher C-max (ratio 1.25 with 95% CI 1.10-1.44) and AUC (ratio 1.25 with 95% CI 1.05-1.49) values than males but the differences were due to the higher body weights of the males; weight-adjusted apparent total clearance values (CL/F) were not different between genders (ratio 1.03 with 95% CI 0.87-1.21). Conclusions Food intake and gender have no significant effect on the exposure to orally administered tucaresol.