Non-alcoholic fatty liver disease is a chronic, serious, life-threatening, inflammatory liver disease characterized by increased liver fat content, inflammation, and progressive fibrosis. The overall prevalence of non-alcoholic fatty liver disease is rapidly rising world-wide. ECC4703 is a potential new treatment for non-alcoholic fatty liver disease. The purpose of this research is to investigate the safety, tolerability and pharmacokinetics of sulfasalazine and pitavastatin when combined with ECC4703.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
ECC4703 will be administered orally.
Sulfasalazine will be administered orally.
Pitavastatin will be administered orally.
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
RECRUITINGMaximum plasma concentration of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Time to maximum plasma concentration of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Area under the drug concentration-time curve of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Clearance of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Maximum plasma concentration of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Time to maximum plasma concentration of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Area under the drug concentration-time curve of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
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Clearance of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)
Time frame: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Number of participants with Adverse Events (AEs), as assessed by a 5-point scale, CTCAE v5.0
Adverse event monitoring includes measuring the frequency, severity and relationship of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) leading to treatment or study discontinuation. Severity of adverse events will be characterised from 1 (mild) to 5 (death).
Time frame: From baseline to follow-up visit (on Day 19).
Change from Baseline in blood pressure, measured using a sphygmomanometer via a cuff on the arm
Time frame: From baseline to follow-up visit (on Day 19).
Change from Baseline in heart rate, measured in beats-per-minute by a vital signs machine
Time frame: From Baseline to follow-up visit (on Day 19).
Change from Baseline in respiratory rate, measured in breaths-per-minute manually via a 60-second count
Time frame: From Baseline to follow-up visit (on Day 19).
Change from Baseline in body temperature in degrees Celsius, measured using a thermometer
Time frame: From Baseline to follow-up visit (on Day 19).
Changes from Baseline in Clinical Laboratory Parameters including, but not limited to, haematology and blood chemistry.
Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse Event (AE). The severity of each AE (and SAE or Serious Adverse Event) will be graded using a 5-point scale
Time frame: From baseline to follow-up visit (on Day 19)