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Not yet recruitingNCT07873229Updated Oct 14, 2026

DDI Study of ECC0509 With Metformin, Midazolam, and Caffeine

A Phase 1 interventional study of ECC0509 and Metformin in Steatohepatitis, Nonalcoholic and Osteo Arthritis, sponsored by Eccogene. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Eccogene · Phase 1, Interventional, and Treatment

Updated Oct 14, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 caffeine (a CYP1A2 probe substrate).

02

Conditions studied

  • Steatohepatitis, Nonalcoholic
  • Osteo Arthritis
03

In context

Non-alcoholic Fatty Liver Disease

1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Eccogene is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Cohort 1 - ECC0509 and Metformin

    Cohort 1 participants will receive ECC0509 and metformin.

    Drug: ECC0509 · Drug: Metformin

  • Experimental
    Cohort 2 - ECC0509 and Caffeine, Midazolam

    Cohort 2 participants will receive ECC0509 and Caffeine, Midazolam

    Drug: ECC0509 · Drug: Caffeine · Drug: Midazolam

Interventions

  • DrugECC0509

    ECC0509 will be administered orally.

  • DrugMetformin

    Metformin will be administered orally.

  • DrugCaffeine

    Caffeine will be administered orally.

  • DrugMidazolam

    Midazolam will be administered orally.

06

What researchers measure

Primary outcomes

  1. Maximum plasma concentration of metformin in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)

    Time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 6 and 7

  2. Time to maximum plasma concentration of metformin in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)

    Time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 6 and 7

  3. 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)

    Time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 6 and 7

  4. Clearance of metformin in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)

    Time frame: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 6 and 7

  5. Maximum plasma concentration of caffeine and midazolam in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)

    Time frame: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 16 and 17

  6. 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)

    Time frame: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 16 and 17

  7. 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)

    Time frame: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 16 and 17

  8. Clearance of caffeine and midazolam in the blood of participants who have taken ECC0509 (as part of called pharmacokinetic or 'PK' testing)

    Time frame: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 16 and 17

Secondary 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 14 in Cohort 1, or On Day 24 in Cohort 2)

  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 14 in Cohort 1, or On Day 24 in Cohort 2)

  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 14 in Cohort 1, or On Day 24 in Cohort 2)

  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 14 in Cohort 1, or On Day 24 in Cohort 2)

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

    Time frame: From baseline to follow-up visit (on Day 14 in Cohort 1, or On Day 24 in Cohort 2)

  6. 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

    Time frame: From baseline to follow-up visit (on Day 14 in Cohort 1, or On Day 24 in Cohort 2)

  7. 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

    Time frame: From baseline to follow-up visit (on Day 14 in Cohort 1, or On Day 24 in Cohort 2)

07

Study locations

1 site
  • Nucleus Network Pty Ltd
    Melbourne, Victoria 3004, Australia
    • Phil Ryan, Dr. · Contact · +61 (03) 8593 9801
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.

Of 94 industry-sponsored phase 1 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's planned 4 months is below that.

Counting every sponsor, half of 116 studies reached it within 11 months; a quarter within 5 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2026
First posted
Oct 14, 2026
StartEst.
Nov 2026
Primary completionEst.
Mar 2027
CompletionEst.
Apr 2027
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07873229
Lead sponsor
Eccogene
Responsible party
Sponsor
First posted
Oct 14, 2026
Start date
Nov 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Oct 14, 2026

Study contacts

Eccogene Clinical Trials
Contact
contact@eccogene.com
86-21-61053022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: ECC0509 · Metformin · Caffeine · Midazolam

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