Investigation of the Effect of NNC0194-0499 on Pharmacokinetics of a Combined Oral Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential. .
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- (AUC0-24h,EE,SS), area under the ethinylestradiol plasma concentration-time curve during a dosing interval at steady state
研究概览
简要总结
The study will investigate the influence of NNC0194-0499 on the blood levels of the two components of a birth control pill, Microgynon®. Participants will get the birth control pill in form of tablets in two periods of 8 days each.
Participants will get NNC0194-0499 as injection under the skin of their thigh. The injections will be given once weekly for 5 weeks.
The study will last for about 11 to 15 weeks, depending on the length of the screening period.
Participants will have to stay overnight at the study centre (2 nights and 4 nights, respectively) Only healthy women who are not able to bear children can take part in this study.
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
- 是
入选标准
- •Female of non-childbearing potential.
- •Age 18-65 years (both inclusive) at the time of signing the informed consent.
- •Body mass index (BMI) between 18.5 and 29.9 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 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 Prescription Drug Information.
- •Sitting blood pressure at screening outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic.
- •Pulse outside the range of 50-89 beats/minute at screening
- •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: use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), or topical medication not reaching systemic circulation.
- •Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.
研究组 & 干预措施
Sequence 1
All participants will be exposed to both interventions in a defined sequence. OC 8 days, NNC0194-0499 4 weeks, OC/NNC0194-0499 combined 1 week.
干预措施: NNC0194-0499 (Drug)
Sequence 1
All participants will be exposed to both interventions in a defined sequence. OC 8 days, NNC0194-0499 4 weeks, OC/NNC0194-0499 combined 1 week.
干预措施: ethinylestradiol/levonorgestrel (Drug)
结局指标
主要结局
(AUC0-24h,EE,SS), area under the ethinylestradiol plasma concentration-time curve during a dosing interval at steady state
时间窗: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
h-pg/mL
(AUC0-24h,LN,SS), area under the levonorgestrel plasma concentration-time curve during a dosing interval at steady state
时间窗: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
h-pg/mL
次要结局
- (Cmax,EE,SS), maximum concentration of ethinylestradiol at steady state(Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose))
- (Cmax,LN,SS), maximum concentration of levonorgestrel at steady state(Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose))
- (tmax,EE,SS), time to maximum concentration of ethinylestradiol at steady state(Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose))
- (tmax,LN,SS), time to maximum concentration of levonorgestrel at steady state(Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose))
- Number of treatment emergent adverse events (TEAEs)(Day 1 to Day 8, and Day 31 to Day 38.)