Study of ECC4703 With Sulfasalazine and Pitavastatin
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEccogene
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- ECC4703
- Sulfasalazine
- Pitavastatin
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov