Effects of age, gender, and race/ethnicity on the pharmacokinetics of posaconazole in healthy volunteers.
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.
Sansone-Parsons
Angela
A
Schering-Plough Research Institute, K15-4-4455, 2015 Galloping Hill Rd., Kenilworth, NJ 07033, USA. angela.sansone@spcorp.com
Krishna
Gopal
G
Simon
Jason
J
Soni
Peter
P
Kantesaria
B
B
Herron
Jerry
J
Stoltz
Randall
R
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
D000935:Antifungal Agents; D014230:Triazoles; C101425:posaconazole