Effect of age and gender on the safety, tolerability, and pharmacokinetics of BAY 12-9566 in healthy subjects.
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.
Lathia
C
C
Bayer Corporation, 400 Morgan Lane, West Haven, CT 06516-4175, USA.
Shah
A
A
Sundaresan
P
P
D000328:Adult; D017677:Age Distribution; D000368:Aged; D000375:Aging / Q000378:metabolism*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001713:Biphenyl Compounds; D004311:Double-Blind Method; D005260:Female; D006207:Half-Life; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D009930:Organic Chemicals; D010654:Phenylbutyrates; D017678:Sex Distribution
D000970:Antineoplastic Agents; D001713:Biphenyl Compounds; D009930:Organic Chemicals; D010654:Phenylbutyrates; C113281:Bay 12-9566