Odanacatib, a Selective Cathepsin K Inhibitor, Demonstrates Comparable Pharmacodynamics and Pharmacokinetics in Older Men and Postmenopausal Women

摘要: Background: Odanacatib is a cathepsin K inhibitor in development for the treatment of osteoporosis. Evaluation therapies to ensure that effects are relevant regardless sex clinically important. Methods: In this double-blind, randomized controlled trial, older men (aged 50–75 years) and postmenopausal women 45–75 were given odanacatib 50 mg once weekly or placebo 4 weeks. Pharmacodynamic (PD) evaluation measured weighted average inhibition (WAI) urine amino-terminal cross-linked telopeptide type I collagen/creatinine (uNTx/Cr) after administration. Pharmacokinetic (PK) parameter data collected, an analysis as factor PK/PD relationship was conducted. Adverse events monitored. The hypotheses WAI uNTx/Cr would be >40% (including lower limit 90% confidence intervals [CIs]) women, there no important differences area under curve from 0 168 ho...