Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sca-136 Administered Orally to Healthy Male Japanese Subjects

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 24 人开始时间: 2006年6月1日最近更新: 2009年8月7日

适应症

试验速览

Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of SCA-136 in healthy male Japanese subjects

•Men aged 20 to 45 years at the time of obtaining informed consent.
•Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight ≥ 50 kg.
•Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

•Presence or history of any disorder that may prevent the successful completion of the study.
•Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
•Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion (ADME) of the test article (eg, resection of liver, kidney, or gastrointestinal tract).

safety and tolerability

未报告次要终点

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry