A Research Study on How UBT251 Affects Levels of Midazolam, Caffeine and Warfarin in the Blood of Participants With Excess Body Weight

Официальное название

An Open-label, Single-sequence, Crossover Study Investigating the Influence of UBT251 on Pharmacokinetics of Index Substrates for Cytochrome P450 Enzymes in Participants With Overweight or Obesity

Обзор

The purpose of this clinical study is to find out if UBT251 is safe and effective to be taken together with medicines, like midazolam, caffeine and warfarin in participants living with overweight or obesity.

Вмешательства

• Препарат UBT251
  Administered subcutaneously.
• Препарат Cocktail (Warfarin/Caffeine/Midazolam)
  Administered orally.

Первичные конечные точки

• AUC0-∞,s-warfarin: The area under the plasma s-warfarin concentration-time curve extrapolated to infinity after single dose [Срок оценки: From pre-dose on Day 1 up to 156 days]
• AUC0-∞,caffeine : The area under the plasma caffeine concentration-time curve extrapolated to infinity after single dose [Срок оценки: From pre-dose on Day 1 up to 156 days]
• AUC0-∞,midazolam: The area under the midazolam concentration-time curve extrapolated to infinity after single dose [Срок оценки: From pre-dose on Day 1 up to 156 days]

Вторичные конечные точки (3)

• Cmax,s-warfarin: The maximum observed plasma s-warfarin concentration after single dose [Срок оценки: From pre-dose on Day 1 up to 156 days]
• Cmax,caffeine: The maximum observed plasma caffeine concentration after single dose [Срок оценки: From pre-dose on Day 1 up to 156 days]
• Cmax,midazolam: The maximum observed plasma midazolam concentration after single dose [Срок оценки: From pre-dose on Day 1 up to 156 days]

Критерии участия

Критерии включения

• Male or female (sex assigned at birth, inclusive of all gender identities).
• Age 18-65 years (both inclusive) at the time of signing the informed consent.
• BMI between 27.0-39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• Body weight >=60.0 kg.
• Considered to be generally healthy, except for overweight or obesity, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Критерии исключения

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Treatment with any marketed product containing compounds with glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), or glucagon (GCG) receptor agonism within 90 days before screening.
• Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic CYP pathways, such as perikon (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of acetaminophen, ibuprofen, or topical medication not reaching systemic circulation.
• Any contraindications for the use of caffeine, midazolam, and warfarin used in the study according to Vivarin®, Midazolam®, and warfarin sodium product information.
• Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
• History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Altasciences Clinical LA, Inc. — Cypress

Идентификаторы

NCT: NCT07710768 · NN9559-8621 · U1111-1332-5554

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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