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First published on October 9, 2007, doi:10.1177/0091270007306563

The Journal of Clinical Pharmacology 2007;47:1489.

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©© 2007 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology , 10.1177/0091270007306563

Article

Pharmacodynamics and Pharmacokinetics of AMG 531, a Thrombopoiesis-Stimulating Peptibody, in Healthy Japanese Subjects: A Randomized, Placebo-Controlled Study

Yuji Kumagai 1*, Tomoe Fujita 1, Machiko Ozaki 1, Kunihiko Sahashi 1, Masayuki Ohkura 2, Tomoko Ohtsu 2, Yoshihiro Arai 2, Yusuke Sonehara 2, and Janet L. Nichol 3

1 Kitasato University East Hospital
2 Amgen Limited, Tokyo, Japan
3 Amgen, Thousand Oaks, California

* To whom correspondence should be addressed. E-mail: fumikos{at}amgen.com.


  Abstract
AMG 531 is a novel thrombopoiesis-stimulating peptibody being investigated for the treatment of chronic immune thrombocytopenic purpura. This double-blind, phase I study evaluated the safety, pharmacodynamics, and pharmacokinetics of AMG 531 in healthy Japanese men. Thirty subjects were randomly assigned 4:1 (AMG 531/placebo) to receive 1 dose of AMG 531 (0.3, 1, or 2 µg/kg) or placebo by subcutaneous injection; subjects were evaluated for 6 weeks. AMG 531 was generally well tolerated, with adverse events similar to placebo. Treatment-related adverse events (headache, "feeling hot," malaise) were reported for 5 of 24 AMG 531–treated subjects. Platelets generated after exposure to AMG 531 functioned normally. Four of 8 subjects receiving 1 µg/kg and 7 of 8 receiving 2 µg/kg had platelet count increases ≥1.5-fold over baseline, an effect similar to that seen in non-Japanese subjects. Serum AMG 531 concentrations were below the lower limit of quantification in all but 2 subjects receiving 2 µg/kg.
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T. B. Gernsheimer
The Pathophysiology of ITP Revisited: Ineffective Thrombopoiesis and the Emerging Role of Thrombopoietin Receptor Agonists in the Management of Chronic Immune Thrombocytopenic Purpura
Hematology, January 1, 2008; 2008(1): 219 - 226.
[Abstract] [Full Text] [PDF]


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