Dyslipidaemia, Non-alcoholic Fatty Liver Disease (NAFLD)
Conditions
Keywords
BCRP inhibitor, OATP inhibitor
Brief summary
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.
Interventions
DRUGECC4703
ECC4703 will be administered orally.
DRUGSulfasalazine
Sulfasalazine will be administered orally.
DRUGPitavastatin
Pitavastatin will be administered orally.
Sponsors
Eccogene
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female between the ages of 18 and 65 years, inclusive, at the time of Screening. * Are healthy and in the opinion of the Investigator have an acceptable medical history (free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological, infective, or psychiatric diseases as determined by medical history over the past 5 years, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests). * Has not consumed and agrees to abstain from taking any prescription drugs or non-prescription drugs for 7 days or 5 half-lives (whichever is longer) prior to first dose of trial treatment and continuing through end of the Treatment Period.
Exclusion criteria
* Has a history of significant renal, hepatic, cardiovascular, psychiatric, neoplastic, thyroid disease/abnormality or other disease which, in the opinion of the Investigator, represents a safety risk for taking part in the trial. * Has a history of sensitivity to any of the trial treatments (and/or their excipients), or severe drug or other allergy * Has a history of drug abuse within the previous 2 years, or a positive drug screen at Screening and/or Day -1. * Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day * Has a history or current diagnosis of a significant psychiatric disorder that would, in the opinion of the Investigator, affect the participant's ability to comply with the trial requirements. * Has a personal or family history of hereditary muscular disorders, previous statin-induced myopathy/rhabdomyolysis, or unexplained repeated or severe muscle pain. * Has a history of any unexplained chronic skin rash or autoimmune skin diseases. * Has a personal or family history of Stevens-Johnson syndrome (SJS), or other severe drug-induced skin reactions. * History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing) | 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) | 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) | 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) | 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) | 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) | 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) | Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12 |
| Clearance of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing) | Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events (AEs), as assessed by a 5-point scale, CTCAE v5.0 | From baseline to follow-up visit (on Day 19). | 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). |
| Change from Baseline in blood pressure, measured using a sphygmomanometer via a cuff on the arm | 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 | 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 | From Baseline to follow-up visit (on Day 19). | — |
| Change from Baseline in body temperature in degrees Celsius, measured using a thermometer | 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. | From baseline to follow-up visit (on Day 19) | 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 |
Countries
Australia
Contacts
CONTACTEccogene Clinical Trials
Outcome results
None listed