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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- AUC0-∞,s-warfarin: The area under the plasma s-warfarin concentration-time curve extrapolated to infinity after single dose
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
UBT251
UBT251 will be administered subcutaneously with gradual dose escalation during the study.
干预措施: UBT251 (Drug)
Cocktail (Warfarin/Caffeine/Midazolam)
A cocktail containing warfarin, caffeine, and midazolam will be administered at predefined study visits to evaluate the effect of UBT251 on the pharmacokinetics of CYP enzyme substrates.
干预措施: Cocktail (Warfarin/Caffeine/Midazolam) (Drug)
结局指标
主要结局
AUC0-∞,s-warfarin: The area under the plasma s-warfarin concentration-time curve extrapolated to infinity after single dose
时间窗: From pre-dose on Day 1 up to 156 days
Measured in nanogram hour per millilitre (ng\*h/mL).
AUC0-∞,caffeine : The area under the plasma caffeine concentration-time curve extrapolated to infinity after single dose
时间窗: From pre-dose on Day 1 up to 156 days
Measured in ng\*h/mL.
AUC0-∞,midazolam: The area under the midazolam concentration-time curve extrapolated to infinity after single dose
时间窗: From pre-dose on Day 1 up to 156 days
Measured in ng\*h/mL.
次要结局
- Cmax,s-warfarin: The maximum observed plasma s-warfarin concentration after single dose(From pre-dose on Day 1 up to 156 days)
- Cmax,caffeine: The maximum observed plasma caffeine concentration after single dose(From pre-dose on Day 1 up to 156 days)
- Cmax,midazolam: The maximum observed plasma midazolam concentration after single dose(From pre-dose on Day 1 up to 156 days)