Resource Center

May 14, 2016
  |  Poster

Relationship of Cariprazine Plasma Concentration to Efficacy and Safety in Patients With Schizophrenia or Bipolar Mania

Abstract

Introduction: Population exposure‑response analysis was undertaken to describe the relationship of drug concentrations to measures of clinical efficacy and safety in patients with schizophrenia or bipolar mania.

Methods: Data were obtained from >800 patients with bipolar mania who were randomized to cariprazine (3–12 mg/d) or placebo in two 3‑week, double‑blind, placebo‑controlled Phase 3 studies. Data were obtained from >1700 patients with
schizophrenia who were administered cariprazine (1.5–21 mg/d) or placebo in two Phase 1b and five Phase 2/3 studies
(3–6‑week, double‑blind, placebo‑controlled studies). Exposure metrics based on total cariprazine [nM] (defined as the molar sum of cariprazine and its two major metabolites of similar pharmacological activity, desmethyl‑cariprazine [DCAR] and didesmethyl‑cariprazine [DDCAR]) were explored for potential relationships with efficacy and safety endpoints. Modeling was performed with NONMEM, a nonlinear mixed‑effects modeling software package, utilizing standard pharmacometric techniques.

American Psychiatric Association (APA) Annual Meeting. May 14-18, 2016, Atlanta, GA.

By Timothy Carrothers, ScD, Susan Willavize, PhD, David Jaworowicz, PhD, Julie Passarell, MA, Antonia Periclou, PhD, Parviz Ghahramani, PhD, Suresh Durgam, MD, Willie Earley, MD, Margit Kapás, PhD, Tatiana Khariton, PhD

Contact Us About This Poster