Study of ECC4703 With Sulfasalazine and Pitavastatin

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат ECC4703
  ECC4703 will be administered orally.
• Препарат Sulfasalazine
  Sulfasalazine will be administered orally.
• Препарат Pitavastatin
  Pitavastatin will be administered orally.

Первичные конечные точки

• Maximum plasma concentration of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Nucleus Network Pty Ltd — Melbourne

Идентификаторы

NCT: NCT07726368 · EC0012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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