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Набор скоро начнётся NCT07710729

A Research Study Looking Into How UBT251 Works With Birth Control Tablets and Emptying of the Stomach in Women With Excess Body Weight Not Able to Become Pregnant

Фаза I С лечением Overweight Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: UBT251, Oral contraceptive, Acetaminophen.
Кому может быть актуально
Состояния в реестре: Overweight, Obesity. Базовые параметры: 18 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Single-Centre, Open-Label Study of the Effect of UBT251 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Women of Non-Childbearing Potential 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 birth control tablets, and emptying of the stomach in women not able to become pregnant living with overweight or obesity

Вмешательства

  • Препарат UBT251
    Administered subcutaneously.
  • Препарат Oral contraceptive
    Administered orally.
  • Препарат Acetaminophen
    Administered orally.

Первичные конечные точки

  • AUC,EE,SS: The area under the EE plasma concentration time curve during a dosing interval at steady state [Срок оценки: From pre-dose on Day 8 up to 157 days]
  • AUC ,LN,SS: The area under the LN plasma concentration time curve during a dosing interval at steady state [Срок оценки: From pre-dose on Day 8 up to 157 days]
Вторичные конечные точки (4)
  • Cmax,EE,SS: Maximum EE plasma concentration at steady state [Срок оценки: From pre-dose on Day 8 up to 157 days]
  • Cmax,LN,SS: Maximum LN plasma concentration at steady state [Срок оценки: From pre-dose on Day 8 up to 157 days]
  • AUC,para: The area under the acetaminophen plasma concentration-time curve [Срок оценки: From pre-dose on Day 1 up to 150 days]
  • Cmax,para: Maximum observed acetaminophen plasma concentration [Срок оценки: From pre-dose on Day 1 up to 150 days]

Критерии участия

Критерии включения

  • Female (sex assigned at birth) of NCBP.
  • Age 18-65 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (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 compound containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), or glucagon (GCG) receptor agonism within 90 days before screening.
  • Any contraindications for the use of the oral contraception used in the study according to the PORTIA Product Information.
  • Use of hormone replacement therapy within 28 days before screening or intention to initiate treatment with hormone replacement therapy during the study.
  • Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as perikon (St. John's Wort), 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 and acetylsalicylic acid, or topical medication not reaching systemic circulation.
  • 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

Канада · 1 центр
  • Altasciences Clinical Company, Inc — Montreal

Идентификаторы

NCT: NCT07710729 · NN9559-8619 · U1111-1332-9333

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗