Semi-Mechanistic PK/PD Model Effect Odanacatib, a Cathespin K Inhibtor, on Bone Turnover to Characterize Lumbar Spine Bone Mineral Density in Two Phase II Studies of Postmenopausal Women

Authors: Jaworowicz DJ
Conference: SLP MIDD+
Keywords: Cathepsin K Inhibitor, lumbar spine bone, Odanacatib, ODN treatment, Phase II, PK/PD model, postmenopausal women, SLP MIDD+ Virtual Conference, SLP2021MIDD
Division: Clinical Pharmacology and Pharmacometrics (CPP)

David Jaworowicz, Senior Director of Pharmacokinetics/Pharmacodynamics, presents objectives, study design, and data analysis for the semi-mechanistic PK/PD model of the effect of Odanacatib in Phase II studies of postmenopausal women.

Topics covered:

  • Development of a semi-mechanistic population PK/PD model to simultaneously characterize the time course of the bone resorption biomarker uNTx (urinary amino-terminal cross-linked telopeptides of Type 1 collagen) and the corresponding lumbar spine BMD response following long-term once-weekly ODN treatment
  • Exposure-response profiles for Osteoclast cycling and bone resorption and corresponding Osteoclast profiles
  • and more!

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Presented at SLP MIDD+ Virtual Conference March 3-4, 2021