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PHARMACOKINETICS AND PHARMACODYNAMICS

Clinical Pharmacology of Multiple Doses of Lasofoxifene in Postmenopausal Women

Mark Gardner, PhD, Ann Taylor, MD, Greg Wei, PhD, Albert Calcagni, Jr, Barbara Duncan and Ashley Milton, PhD

From Pfizer Inc, Groton, Connecticut.

Lasofoxifene, a next-generation selective estrogen receptor modulator, is undergoing phase 3 clinical development for osteoporosis. This study evaluated daily lasofoxifene for 14 days in healthy postmenopausal women. A loading dose of 5 times the daily dose was followed by daily doses of 0.01 mg (n = 8), 0.03 mg (n =8), 0.1 mg(n = 16), 0.3 mg (n =9), 1 mg (n = 8), or placebo (n = 16). Samples were collected for pharmacokinetic and pharmacodynamic assessments. Lasofoxifene was well tolerated; study drug–associated adverse events were mild and unrelated to dose. There was a predictable increase in plasma concentrations of lasofoxifene with dose. Pharmacokinetic parameters included mean half-life of 165 hours, mean area under the plasma concentration-time curve from time 0 to 24 hours ranging from 1.67 ng·h/mL to 137 ng·h/mL, and mean maximum observed plasma concentration ranging from 0.09 ng/mL to 6.43 ng/mL. Lasofoxifene partially suppressed luteinizing hormone, follicle-stimulating hormone, low-density lipoprotein, and N-telopeptide.

Key Words: Lasofoxifene • osteoporosis • pharmacology • pharmacokinetics • pharmacodynamics

Address for reprints: Ashley Milton, PhD, Pfizer Global Research and Development, Eastern Point Road, Groton, CT 06340.


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