title: Effects of age, gender, and race/ethnicity on the pharmacokinetics of posaconazole in healthy volunteers.
abstract: Posaconazole is a triazole antifungal for prophylaxis of invasive fungal infection and treatment of oropharyngeal candidiasis. We evaluated the effects of gender, age, and race/ethnicity (black or white) on the steady-state pharmacokinetics of posaconazole in two studies on healthy adult subjects (>or=18 years of age). Additionally, we explored the effect of P-glycoprotein expression and MDR1 genotype on posaconazole pharmacokinetics in black and white subjects. Age, gender, and race/ethnicity had no clinically relevant effects on posaconazole pharmacokinetics. No association was observed between any MDR1 single-nucleotide polymorphism and the area under the concentration-time curve for posaconazole. Posaconazole was safe and well tolerated regardless of age, gender, or race/ethnicity. In conclusion, age, gender, and race/ethnicity have no clinically relevant effects on the steady-state pharmacokinetics of posaconazole in healthy adults; therefore, dosage adjustments based on these covariates are unnecessary.
authors.affiliation: Schering-Plough Research Institute, K15-4-4455, 2015 Galloping Hill Rd., Kenilworth, NJ 07033, USA. angela.sansone@spcorp.com
authors.forename: Angela
authors.initials: A
authors.lastname: Sansone-Parsons
authors.forename: Gopal
authors.initials: G
authors.lastname: Krishna
authors.forename: Jason
authors.initials: J
authors.lastname: Simon
authors.forename: Peter
authors.initials: P
authors.lastname: Soni
authors.forename: B
authors.initials: B
authors.lastname: Kantesaria
authors.forename: Jerry
authors.initials: J
authors.lastname: Herron
authors.forename: Randall
authors.initials: R
authors.lastname: Stoltz
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000378:metabolism / Q000493:pharmacokinetics*; D044383:Black People; D018432:Drug Resistance, Multiple; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012737:Sex Factors; D014230:Triazoles / Q000378:metabolism / Q000493:pharmacokinetics*; D044465:White People
chemical_list: D000935:Antifungal Agents; D014230:Triazoles; C101425:posaconazole