A Phase 1 Drug-Drug Interaction Study of ABBV-295, Levonorgestrel, and Ethinyl Estradiol in Healthy Adult Female Subjects With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
This Study of ABBV-295 subcutaneous injections will assess pharmacokinetics and adverse events in healthy adult women participants with overweight or obesity taking oral contraceptives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •BMI ≥ 25.0 to ≤ 35.0 kg/m2 after rounding to the tenths decimal at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters)
- •A female who is not pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 60 days after the last dose of study treatment.
排除标准
- •Participant has a self-reported change in body weight ≥ 5% within 3 months prior to Screening.
- •HbA1c ≥ 6.5% and/or serum glucose ≥ 126 mg/dL at Screening.
- •Participant has taken a medication for the purpose of treating obesity or has been enrolled in an obesity trial within 90 days prior to study treatment administration.
研究组 & 干预措施
ABBV-295 with Levonorgestrel and Ethinyl Estradiol
Participants will receive subcutaneous doses of ABBV-295 with levonorgestrel and ethinyl estradiol for 68 days.
干预措施: ABBV-295 (Drug)
ABBV-295 with Levonorgestrel and Ethinyl Estradiol
Participants will receive subcutaneous doses of ABBV-295 with levonorgestrel and ethinyl estradiol for 68 days.
干预措施: Levonorgestrel/Ethinyl Estradiol (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 128 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
次要结局
未报告次要终点