Investigation of the Effect of NNC0487-0111 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Females of Non-childbearing Potential
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- The area under the ethinylestradiol plasma concentration time curve at steady state
研究概览
简要总结
This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. The study medicine will taken orally for 18 weeks and then study medicine will be injected with a thin needle in a skin fold in the abdomen for 9 weeks.The study will last for about 35 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Females of non-childbearing potential.
- •Age 18 - 65 years (both inclusive) at the time of signing the informed consent.
- •Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive) at screening.
- •Considered to be generally healthy 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
- •Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Any contraindications for the use of the oral contraception used in the study according to the Microgynon Product Information.
- •Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic CYP pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening.
- •Exceptions are routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
- •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.
- •Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
研究组 & 干预措施
NNC0487-0111
Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4.
干预措施: NNC0487-0111 C (Drug)
NNC0487-0111
Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4.
干预措施: NNC0487-0111 A (Drug)
NNC0487-0111
Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4.
干预措施: Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) (Drug)
NNC0487-0111
Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4.
干预措施: Acetaminophen - 500 mg/15 ml (Drug)
结局指标
主要结局
The area under the ethinylestradiol plasma concentration time curve at steady state
时间窗: Day 8 and Day 193
Measured as hours picograms per milliliter (h\*pg/mL).
The area under the levonorgestrel plasma concentration time curve at steady state
时间窗: Day 8 and Day 193
Measured as hours picograms per milliliter (h\*pg/mL).
次要结局
- The area under the ethinylestradiol plasma concentration time curve at steady state(Day 8 and Day 135)
- Maximum ethinylestradiol plasma concentration at steady state(Day 8 and Day 193)
- AUC1 area under the acetaminophen concentration-time curve following a standardised meal(Day 1 and Day 186)
- Cmax,para, maximum acetaminophen plasma concentration following a standardised meal(Day 1 and Day 128)
- AUC3 area under the acetaminophen concentration-time curve following a standardised meal(Day 1 and Day 128)
- Maximum levonorgestrel plasma concentration at steady state(Day 8 and Day 193)
- AUC2 area under the acetaminophen concentration-time curve following a standardised meal(Day 1 and Day 186)
- The area under the levonorgestrel plasma concentration time curve at steady state(Day 8 and Day 135)
- Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state(Day 8 and Day 135)
- AUC4 area under the acetaminophen concentration-time curve following a standardised meal(Day 1 and Day 128)
- Cmax,LN,SS, maximum levonorgestrel plasma concentration at steady state(Day 8 and Day 135)