Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Encenicline, a Selective α7 Nicotinic Receptor Partial Agonist, in Single Ascending-dose.

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Presentation transcript:

Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Encenicline, a Selective α7 Nicotinic Receptor Partial Agonist, in Single Ascending-dose and Bioavailability Studies Ann J. Barbier, MD, PhD, Martijn Hilhorst, PhD, André Van Vliet, MD, PhD, Peter Snyder, PhD, Michael G. Palfreyman, PhD, Maria Gawryl, PhD, Nancy Dgetluck, MS, Monica Massaro, MS, Renger Tiessen, MD, PhD, Wia Timmerman, MS, Dana C. Hilt, MD Clinical Therapeutics Volume 37, Issue 2, Pages 311-324 (February 2015) DOI: 10.1016/j.clinthera.2014.09.013 Copyright © 2015 The Authors Terms and Conditions

Figure 1 Arithmetic mean (SD) plasma concentration versus time profiles for encenicline at doses of 1 to 180 mg as an oral solution. (A) Linear and (B) semi-log plot. Clinical Therapeutics 2015 37, 311-324DOI: (10.1016/j.clinthera.2014.09.013) Copyright © 2015 The Authors Terms and Conditions

Figure 2 Mean (SE) modified Dunlap’s d change scores for Digit Symbol Substitution Test by encenicline dose level and time. *p ≤ 0.050 versus placebo. Clinical Therapeutics 2015 37, 311-324DOI: (10.1016/j.clinthera.2014.09.013) Copyright © 2015 The Authors Terms and Conditions

Figure 3 Arithmetic mean (SD) plasma concentration versus time profiles for encenicline after administration of 1-mg oral capsule in fasted and fed states or 1-mg oral solution in fasted state. Clinical Therapeutics 2015 37, 311-324DOI: (10.1016/j.clinthera.2014.09.013) Copyright © 2015 The Authors Terms and Conditions

Figure 4 Arithmetic mean (SD) plasma concentration versus time profiles for encenicline after administration of 1-mg oral capsule or solution in fasted state in males and females. Clinical Therapeutics 2015 37, 311-324DOI: (10.1016/j.clinthera.2014.09.013) Copyright © 2015 The Authors Terms and Conditions

Figure 5 Point estimates and 90% confidence intervals (%) for encenicline AUC and Cmax parameters for the comparisons of encenicline capsules and solution, the effect of food on encenicline capsules, and the sex effect after administration of encenicline oral capsules. Clinical Therapeutics 2015 37, 311-324DOI: (10.1016/j.clinthera.2014.09.013) Copyright © 2015 The Authors Terms and Conditions