None listed
Conditions
Brief summary
The objectives of this study were to compare the serum drug level profiles of PX811019 and triethylenetetramine dihydrochloride at four different doses, and to compare the effect of drug doses on urine copper excretion in normal healthy volunteers
Interventions
This study was a Phase 1, prospective, randomized, double-blind, single-dose, two-way crossover, dose escalation with one-week washout. It was planned that up to four cohorts, with six subjects per cohort, were to be enrolled. PX811019 (TETA.Dis) or triethylenetetramine dihydrochloride (TETA.2HCl) doses were to be administered to subjects within each cohort in a single dose, at approximately molar equivalent doses of triethylenetetramine free base (approximately 166 to 167 mg free base per capsu
This study was a Phase 1, prospective, randomized, double-blind, single-dose, two-way crossover, dose escalation with one-week washout. It was planned that up to four cohorts, with six subjects per cohort, were to be enrolled. PX811019 (TETA.Dis) or triethylenetetramine dihydrochloride (TETA.2HCl) doses were to be administered to subjects within each cohort in a single dose, at approximately molar equivalent doses of triethylenetetramine free base (approximately 166 to 167 mg free base per capsule in both treatments) in 1-, 3-, 5- or 7-capsule doses. Cohort TETA.2HCl (mg) TETA.Dis (mg) No. Capsules 1 250 435 1 2 750 1305 3 3 1250 2175 5 4 1750 3045 7 Each subject had 3 visits to the clinic, a screening visit, and two treatment visits. Following an overnight fast, subjects were randomised to receive a single oral dose of TETA Dihydrochloride or Disuccinate on Day 1, and the alternate treatment on Day 8.
Sponsors
Protemix Corporation
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Outcome results
None listed