A Single Center, Randomized, Double-Blind, Single-Dose, 2-Way Crossover, Dose Escalation Study of the Pharmacokinetics and Pharmacodynamics of PX811019 Compared with triethylenetetramine dihydrochloride in Normal Healthy Volunteers to compare the pharmacokinetic (PK) profiles: to determine the dosing relationship of PX811019 relative to triethylenetetramine dihydrochloride and to characterize the pharmacodynamic profile of urinary copper excretion in response to the study drug.

Protemix Corporation0 个研究点目标入组 24 人开始时间: 2012年7月10日最近更新: 2020年1月13日

试验速览

暂无简介。

•Healthy adult males or females 18-60 years, inclusive, with a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and have normal renal function as calculated by a creatinine clearance >90 mL/min. Females of child-bearing potential had to have a negative pregnancy test at the Screening Visit and upon each admission to the research facility, be willing to use an effective means of birth control for four weeks prior to study medication administration, and be non-lactating. Males must have been willing to use effective barrier contraception for four weeks after study medication administration.

•Adult males or females younger than 18 and older than 60 years,with a body mass index (BMI) lower than 18 and greater than 30 kg/m2, or with abnormal renal function; Pregnant females or those unwilling to take contraceptive measures; Males who were unwilling to take contraceptive measures; smokers; history of drug or alcohol abuse; participation in a clinical research study within 30 days prior to the first dose of study medication; use of iron, copper or other dietary supplements within two weeks prior to the first dose of study medication or during the study; diagnosis of iron deficiency based on levels of plasma iron, iron-binding capacity and ferritin, copper deficiency based on low levels of plasma copper or ceruloplasmin, abnormal liver function test results or a platelet count <100 x 106/L.

发起方

Protemix Corporation