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Not yet recruiting NCT07726368

Study of ECC4703 With Sulfasalazine and Pitavastatin

Phase I Interventional Non-alcoholic Fatty Liver Disease (NAFLD) Dyslipidaemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ECC4703, Sulfasalazine, Pitavastatin.
Who it may be relevant to
Registry conditions: Non-alcoholic Fatty Liver Disease (NAFLD), Dyslipidaemia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Open-Label, Fixed-Sequence, Single-Center, Two-Period, Drug-Drug Interaction Trial in Healthy Adult Participants to Evaluate the Effect of Steady-State ECC4703 on the Pharmacokinetics of Sulfasalazine (BCRP Probe Substrate) and Pitavastatin (OATP1B1/OATP1B3 Probe Substrate)

Overview

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

  • Drug ECC4703
    ECC4703 will be administered orally.
  • Drug Sulfasalazine
    Sulfasalazine will be administered orally.
  • Drug Pitavastatin
    Pitavastatin will be administered orally.

Primary outcome measures

  • 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]
  • 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]
  • 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]
Secondary outcome measures (6)
  • Number of participants with Adverse Events (AEs), as assessed by a 5-point scale, CTCAE v5.0 [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. [Time frame: From baseline to follow-up visit (on Day 19)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Nucleus Network Pty Ltd — Melbourne

Identifiers

NCT: NCT07726368 · EC0012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗