Effect of Lanabecestat on the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel in Healthy Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under The Concentration Curve (AUC) of Ethinyl Estradiol
研究概览
简要总结
The study will evaluate the effect of oral contraceptive (birth control pill) on the blood level of lanabecestat when both are given together. Side effects will be monitored and documented. This study will last up to 27 days for each participant, not including screening. Screening is required within 42 days prior to first dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Are healthy female participants
- •Women not of childbearing potential; women of childbearing potential using a non-hormonal intrauterine device (IUD)
- •Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square (kg/m²)
排除标准
- •Have a history of or current significant ophthalmic disease, which includes participants with clinically significant eye abnormalities, particularly any eye problem involving the retina, as determined by the investigator
- •Have vitiligo or any other clinically significant disorder of skin or hair pigmentation, as determined by the investigator
- •Have a history of or current neuropsychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state, or personality disorder
研究组 & 干预措施
Oral Contraceptive (OC)
Ethinyl estradiol and levonorgestrel administered as a single dose, orally
干预措施: Oral Contraceptive (Drug)
Lanabecestat
Single oral dose of lanabecestat
干预措施: Lanabecestat (Drug)
Lanabecestat and OC
A single oral dose of oral contraceptive and single daily doses of lanabecestat
干预措施: Lanabecestat (Drug)
Lanabecestat and OC
A single oral dose of oral contraceptive and single daily doses of lanabecestat
干预措施: Oral Contraceptive (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under The Concentration Curve (AUC) of Ethinyl Estradiol
时间窗: Baseline though 120 hours after administration of the study drug (lanabecestat)
PK: AUC of Ethinyl Estradiol
PK: Cmax of Levonorgestrel
时间窗: Baseline though 120 hours after administration of the study drug (lanabecestat)
PK: Cmax of Levonorgestrel
PK: AUC of Levonorgestrel
时间窗: Baseline though 120 hours after administration of the study drug (lanabecestat)
PK: AUC of Levonorgestrel
PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol
时间窗: Baseline though 120 hours after administration of the study drug (lanabecestat)
PK: Cmax of Ethinyl Estradiol
次要结局
未报告次要终点