A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Drospirenone and Ethinyl Estradiol in Healthy Adult Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) of COC
研究概览
简要总结
A study to evaluate the impact of Obicetrapib on the PK levels of Drospirenone and Ethinyl Estradiol (COC) in 30 adult female, healthy volunteers.
详细描述
This is an interventional, drug-drug interaction study to evaluate the effect of daily doses of Obicetrapib tablets on the pharmacokinetics of a combined oral contraceptive (COC), Drospirenone and Ethinyl Estradiol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Non-pregnant, non-lactating, non-tobacco-, non-nicotine-using female, 18-35 years of age, inclusive, who is a candidate for hormonal contraception (as determined by the Investigator).
- •Subject has a BMI of 18.5-29.9 kg/m², inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures.
- •If the subject is currently using a hormonal method of contraception, the subject is willing and agrees to stop using her hormonal contraceptive throughout the duration of the study and is prepared to abstain from sexual intercourse or use a reliable non-hormonal method of contraception, as outlined below
排除标准
- •Have given birth or been pregnant within 3 months before initial dosing, or is currently pregnant, lactating or likely to become pregnant during the study.
- •History of Hypertension, or seated blood pressure for a minimum of 5 minutes >140mmHg systolic, or > 80 mmHg, diastolic at screening
研究组 & 干预措施
Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC)
Obicetrapib 10 mg tablets and Drospirenone (3mg)/Ethinyl Estradiol (0.02mg) tablet
干预措施: Obicetrapib (Drug)
Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC)
Obicetrapib 10 mg tablets and Drospirenone (3mg)/Ethinyl Estradiol (0.02mg) tablet
干预措施: Obicetrapib + Drospirenone / Ethinyl Estradiol (COC) (Drug)
Treatment B: Obicetrapib
Obicetrapib 10 mg tablets (daily)
干预措施: Obicetrapib (Drug)
Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC)
Drospirenone (3mg)/Ethinyl Estradiol tablets (0.02mg) tablet
干预措施: Drospirenone / Ethinyl Estradiol (COC) (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of COC
时间窗: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)
Plasma Cmax concentration of COC with and without Obicetrapib
Area under the plasma concentration-time (AUC0-τ) curve for COC with and without coadministration with Obicetrapib
时间窗: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)
Plasma AUC0-τ for COC with and without coadministration of Obicetrapib
次要结局
未报告次要终点