Study of ECC4703 With Sulfasalazine and Pitavastatin
Recruiting · NCT07726368 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Nucleus Network Pty Ltd - Melbourne, Victoria, Australia