A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body Weight

Официальное название

An Investigation of the Effect of NNC0662-0419 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 NNC0662-0419 is safe and effective to be taken together with other medicines, like birth control pills, and emptying of the stomach in women not able to become pregnant living with overweight or obesity. There are 3 study treatments in this study, participants will get all of the treatments, NNC0662-0419 the treatment being tested, Altavera a type of birth control pill, Acetaminophen a common type of mild painkiller.

Вмешательства

• Препарат NNC0662-0419
  Once-weekly subcutaneous NNC0662-0419 will be administered using a pen injector
• Препарат Oral contraceptive
  An oral contraceptive Altavera \[levonorgestrel (LN) 0.15 milligram (mg) and ethinyl estradiol (EE) 0.03 mg\] will be administered orally.
• Препарат Acetaminophen
  A single dose of acetaminophen will be administered orally.

Первичные конечные точки

• Area under curve (AUC) 0-24 h, EE, steady state (SS): The area under the EE plasma concentration-time curve (pre-dose to 24 hours post-dose) [Срок оценки: Day 8 and 1 day after last NNC0662-0419 dose]
• AUC0-24h, LN, SS: The area under the LN plasma concentration-time curve (pre-dose to 24 hours post-dose) [Срок оценки: Day 8 and 1 day after last NNC0662-0419 dose]

Вторичные конечные точки (5)

• Maximum concentration (Cmax), EE, SS: Maximum observed EE plasma concentration (pre-dose to 24 hours post-dose) [Срок оценки: Day 8 and 1 day after last NNC0662-0419 dose]
• Cmax, LN, SS: Maximum observed LN plasma concentration (pre-dose to 24 hours post-dose) [Срок оценки: Day 8 and 1 day after last NNC0662-0419 dose]
• AUC0-60min, para: The area under the paracetamol plasma concentration-time curve (pre-dose to 60 minutes post-dose) following a standardised meal [Срок оценки: Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step]
• AUC0-300min, para: The area under the paracetamol plasma concentration-time curve (pre-dose to 300 minutes post-dose) following a standardised meal [Срок оценки: Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step]
• Cmax, para; Maximum observed paracetamol plasma concentration (pre-dose to 300 minutes post-dose) following a standardised meal [Срок оценки: Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step]

Критерии участия

Критерии включения

• Female (sex assigned at birth) of non-childbearing potential.
• Age 18-64 years (both inclusive) at the time of signing the informed consent.
• Body weight more than or equal to (≥) 60.0 kilogram (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.
• Use of any medication containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), or amylin receptor agonism before screening.
• Any contraindications for the use of the oral contraception used in the study according to the Altavera 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 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

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Altasciences Clinical Kansas, Inc. — Overland Park

Идентификаторы

NCT: NCT07525791 · NN9662-8158 · U1111-1328-3457

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗