A Phase 1 Study to Assess the Effect of Multiple Doses of ABBV-722 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel
研究概览
简要总结
The objective of this study is to assess the effect of repeated doses of ABBV-722 on the single dose pharmacokinetics (PK) of ethinyl estradiol and levonorgestrel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Laboratory values meet the criteria specified in the protocol.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
排除标准
- •History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.
- •Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study treatment administration.
- •Use of tobacco- or nicotine-containing products within 3 months (90 days) prior to the first dose of study treatment.
- •Participant has prior exposure to ABBV-722 within 90 days prior to the first dose of study treatment.
研究组 & 干预措施
Period 1 & 2
In Period 1, participants will receive a single dose of ethinyl estradiol and levonorgestrel. In Period 2, participants will receive multiple daily doses of ABBV-722 and a single dose of ethinyl estradiol and levonorgestrel.
干预措施: ABBV-722 (Drug)
Period 1 & 2
In Period 1, participants will receive a single dose of ethinyl estradiol and levonorgestrel. In Period 2, participants will receive multiple daily doses of ABBV-722 and a single dose of ethinyl estradiol and levonorgestrel.
干预措施: Ethinyl Estradiol + Levonorgestrel (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel
时间窗: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
Cmax of Ethinyl Estradiol and Levonorgestrel.
Time to Cmax (Tmax) of Ethinyl Estradiol and Levonorgestrel
时间窗: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
Tmax of Ethinyl Estradiol and Levonorgestrel.
Terminal Phase Elimination Rate Constant (β) of Ethinyl Estradiol and Levonorgestrel
时间窗: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
β of Ethinyl Estradiol and Levonorgestrel.
Terminal Phase Elimination Half-Life (t1/2) of Ethinyl Estradiol and Levonorgestrel
时间窗: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
t1/2 of Ethinyl Estradiol and Levonorgestrel.
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of Ethinyl Estradiol and Levonorgestrel
时间窗: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
AUCt of Ethinyl Estradiol and Levonorgestrel.
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of Ethinyl Estradiol and Levonorgestrel
时间窗: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
AUCinf of Ethinyl Estradiol and Levonorgestrel.
Number of Participants with Adverse Events (AEs)
时间窗: Up to Approximately 82 Days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
未报告次要终点