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Phase 1 Study of ECC4703 With Sulfasalazine and Pitavastatin

22. juli 2026 opdateret af: Eccogene

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)

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1 - ECC4703 and Sulfasalazine
Cohort 1 participants will receive ECC4703 and sulfasalazine.
Medicin: ECC4703
ECC4703 will be administered orally.
Medicin: Sulfasalazine
Sulfasalazine will be administered orally.
Eksperimentel: Cohort 2 - ECC4703 and Pitavastatin
Cohort 2 participants will receive ECC4703 and pitavastatin.
Medicin: ECC4703
ECC4703 will be administered orally.
Medicin: Pitavastatin
Pitavastatin will be administered orally.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in sulfasalazine levels in the blood of participants who have taken ECC4703 (also called pharmacokinetic or 'PK' testing)
Tidsramme: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Pharmacokinetic (PK) endpoints include (but are not limited to) maximum plasma concentration, time to maximum plasma concentration, area under the drug concentration-time curve, and clearance of the drug will be measured as a composite outcome.
Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Change in pitavastatin levels in the blood of participants who have taken ECC4703 (also called pharmacokinetic or 'PK' testing)
Tidsramme: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12.
Pharmacokinetic (PK) endpoints include (but are not limited to) maximum plasma concentration, time to maximum plasma concentration, area under the drug concentration-time curve, and clearance of the drug will be measured as a composite outcome.
Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with Adverse Events (AEs), as assessed by a 5-point scale, CTCAE v5.0
Tidsramme: 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).
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
Tidsramme: From baseline to follow-up visit (on Day 19).
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
Tidsramme: From Baseline to follow-up visit (on Day 19).
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
Tidsramme: From Baseline to follow-up visit (on Day 19).
From Baseline to follow-up visit (on Day 19).
Change from Baseline in body temperature in degrees Celsius, measured using a thermometer
Tidsramme: From Baseline to follow-up visit (on Day 19).
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.
Tidsramme: 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
From baseline to follow-up visit (on Day 19)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eccogene

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

22. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EC0012

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med ECC4703

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Sponsorer og samarbejdspartnere

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Betingelser

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Placeringer

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