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

Phase 1

Completed

• Conditions: Pharmacokinetics of a study drug for the treatment of diabetic complications; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12612000738820
• Lead Sponsor: Protemix Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified