Study of ECC4703 With Sulfasalazine and Pitavastatin
Trial statusRecruiting
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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
ECC4703
DrugECC4703 will be administered orally.
Sulfasalazine
DrugSulfasalazine will be administered orally.
Pitavastatin
DrugPitavastatin will be administered orally.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Cohort 1 - ECC4703 and SulfasalazineExperimental treatment 2 interventions
Group B: Cohort 2 - ECC4703 and PitavastatinExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 122
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 123
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 124
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 12Secondary outcomes
1
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).2
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).3
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).4
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). Source ClinicalTrials.gov