Study of ECC4703 With Sulfasalazine and Pitavastatin

NCT07726368 | Not Yet Recruiting Phase 1

• 1 other identifier: EC0012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD); Dyslipidaemia

Keywords

BCRP inhibitor; OATP inhibitor

Outcome Measures

Primary Outcomes (8)

• Maximum plasma concentration of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12

Secondary Outcomes (6)

• Number of participants with Adverse Events (AEs), as assessed by a 5-point scale, CTCAE v5.0

  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

  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

  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

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

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

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

Study Arms (2)

Cohort 1 - ECC4703 and Sulfasalazine

EXPERIMENTAL

Cohort 1 participants will receive ECC4703 and sulfasalazine.

Drug: ECC4703; Drug: Sulfasalazine

Cohort 2 - ECC4703 and Pitavastatin

EXPERIMENTAL

Cohort 2 participants will receive ECC4703 and pitavastatin.

Drug: ECC4703; Drug: Pitavastatin

Interventions

ECC4703 DRUG

ECC4703 will be administered orally.

Cohort 1 - ECC4703 and Sulfasalazine; Cohort 2 - ECC4703 and Pitavastatin

Sulfasalazine DRUG

Sulfasalazine will be administered orally.

Cohort 1 - ECC4703 and Sulfasalazine

Pitavastatin DRUG

Pitavastatin will be administered orally.

Cohort 2 - ECC4703 and Pitavastatin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eccogene: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Dyslipidemias

Interventions

Sulfasalazine; pitavastatin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Central Study Contacts

Eccogene Clinical Trials

CONTACT

86-21-61053022; contact@eccogene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)