Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07726368

Study of ECC4703 With Sulfasalazine and Pitavastatin

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD) Digestive System Diseases Dyslipidaemia Dyslipidemias Fatty Liver Lipid Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECC4703

Drug

ECC4703 will be administered orally.

Sulfasalazine

Drug

Sulfasalazine will be administered orally.

Pitavastatin

Drug

Pitavastatin will be administered orally.

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 12

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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 outcomes

  1. 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).

    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).

  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).

  5. Change from Baseline in body temperature in degrees Celsius, measured using a thermometer

    Time frame: From Baseline to follow-up visit (on Day 19).

  6. 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)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Eccogene Clinical Trials

CONTACT

[email protected]

86-21-61053022

Sponsors and collaborators

Lead sponsor

Eccogene

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.