Steatohepatitis, NonalcoholicPhase 1NCT07873229
DDI Study of ECC0509 With Metformin, Midazolam, and Caffeine
A Phase 1 study testing ECC0509, Metformin and Caffeine in people with Steatohepatitis, Nonalcoholic and Osteo Arthritis, run by Eccogene at 1 site in Australia.
Trial summary
This is a Phase 1, open-label, 2-part, fixed-sequence, single-center, two-period, drug-drug interaction trial in healthy adult participants to determine if ECC0509 administration at steady state affects the pharmacokinetics (PK) of metformin (a MATE1/2-K probe substrate), midazolam (a CYP3A4 probe substrate), and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Steatohepatitis, Nonalcoholic, Osteo Arthritis
- What is being tested?
- ECC0509, Metformin and Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2026to Apr 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 excessively consumed beverages/products containing caffeine for the past month (more than 2 cups or glasses a day) or is unable to stop or limit consumption during the trial.
- 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.
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- Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medication.
- History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known pathological arrythmia.
- Presence or having sequelae of gastrointestinal, liver (including Gilbert's syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
Phil Ryan, Dr., +61 (03) 8593 9801
About this study
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 ECC0509 on the Pharmacokinetics of Metformin (MATE1/2-K Probe Substrate), Midazolam (CYP3A4 Probe Substrate), and Caffeine (CYP1A2 Probe Substrate)
This is a Phase 1, open-label, 2-part, fixed-sequence, single-center, two-period, drug-drug interaction trial in healthy adult participants to determine if ECC0509 administration at steady state affects the pharmacokinetics (PK) of metformin (a MATE1/2-K probe substrate), midazolam (a CYP3A4 probe substrate), and caffeine (a CYP1A2 probe substrate).
- Conditions
- Steatohepatitis, Nonalcoholic, Osteo Arthritis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECC0509Drug
ECC0509 will be administered orally.
MetforminDrug
Metformin will be administered orally.
CaffeineDrug
Caffeine will be administered orally.
MidazolamDrug
Midazolam will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - ECC0509 and Metformin | Experimental | Cohort 1 participants will receive ECC0509 and metformin. Receives: Drug: ECC0509; Drug: Metformin |
| Cohort 2 - ECC0509 and Caffeine, Midazolam | Experimental | Cohort 2 participants will receive ECC0509 and Caffeine, Midazolam Receives: Drug: ECC0509; Drug: Caffeine; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration of metformin in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 6 and 7
Time to maximum plasma concentration of metformin in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 6 and 7
Area under the drug concentration-time curve of metformin in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 6 and 7
Clearance of metformin in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 6 and 7
Maximum plasma concentration of caffeine and midazolam in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 16 and 17
Time to maximum plasma concentration of caffeine and midazolam in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 16 and 17
Area under the drug concentration-time curve of caffeine and midazolam in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 16 and 17
Clearance of caffeine and midazolam in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)
Measured: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 16 and 17
Secondary outcomes (7)
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).
Measured: From baseline to follow-up visit (on Day 14 in Cohort 1, or On Day 24 in Cohort 2)
Change from Baseline in blood pressure, measured using a sphygmomanometer via a cuff on the arm
Measured: From baseline to follow-up visit (on Day 14 in Cohort 1, or On Day 24 in Cohort 2)
Change from Baseline in heart rate, measured in beats-per-minute by a vital signs machine
Measured: From baseline to follow-up visit (on Day 14 in Cohort 1, or On Day 24 in Cohort 2)
Change from Baseline in respiratory rate, measured in breaths-per-minute manually via a 60-second count
Measured: From baseline to follow-up visit (on Day 14 in Cohort 1, or On Day 24 in Cohort 2)
Change from Baseline in body temperature in degrees Celsius, measured using a thermometer
Measured: From baseline to follow-up visit (on Day 14 in Cohort 1, or On Day 24 in Cohort 2)
Changes from Baseline in Clinical Laboratory Parameters in haematology.
Blood samples will be collected. All haematology 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
Measured: From baseline to follow-up visit (on Day 14 in Cohort 1, or On Day 24 in Cohort 2)
Changes from Baseline in Clinical Laboratory Parameters in blood chemistry.
Blood samples will be collected. All blood chemistry 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
Measured: From baseline to follow-up visit (on Day 14 in Cohort 1, or On Day 24 in Cohort 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatohepatitis, NonalcoholicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eccogene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873229
- Sponsor's protocol ID
- EC0013
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No