A Phase 1, Open-label Study to Assess the Effect of CTP-543 on the Pharmacokinetics of Oral Contraceptives in Healthy Adult Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This is a Phase 1, fixed sequence, multiple dose, open-label study of the effect of CTP-543 on oral contraceptive pharmacokinetics in healthy female subjects.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •Healthy female participants of non-childbearing potential, or adult females of childbearing potential who agree to use birth control methods described in the protocol
- •If of reproductive age, willing and able to use a medically highly effective form of birth control 28 days prior to first dose, during the study and for 28 days following last dose of study medication. Examples of medically highly effective forms of birth control are:
- •Surgical sterilization of the partner (via vasectomy, hysterectomy, bilateral tubal ligation or bilateral salpingectomy) at least 4 months prior to first dose or post-menopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels (> 40 IU/L) consistent with postmenopausal status
- •Sexual partner is sterile, or of the same sex
- •Double-barrier method (any combination of physical and chemical methods)
- •Non-hormone releasing intrauterine device in females
- •Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
- •Medically healthy with no clinically significant medical history, physical examination, laboratory tests, vital signs, or ECGs
- •Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol
排除标准
- •Positive pregnancy test
- •History or presence of clinically significant medical or psychiatric condition or disease
- •History of any illness that might confound the results of the study or pose an additional risk to the subject by their participation in the study
- •History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- •A positive tuberculosis test at screening or history of incompletely treated or untreated tuberculosis
- •Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- •Donation of blood or significant blood loss within 56 days prior to dosing
研究组 & 干预措施
CTP-543
In Period 1, participants will receive a single oral dose of the combination oral contraceptive (OC) on Day 1. There will be a washout period of 7 days between dosing in Period 1 and the first dose in Period 2. In Period 2, participants will receive twice daily oral doses of CTP-543 for 8 consecutive days with a single dose of the combination OC co-administered on Day 4.
干预措施: CTP-543 (Drug)
CTP-543
In Period 1, participants will receive a single oral dose of the combination oral contraceptive (OC) on Day 1. There will be a washout period of 7 days between dosing in Period 1 and the first dose in Period 2. In Period 2, participants will receive twice daily oral doses of CTP-543 for 8 consecutive days with a single dose of the combination OC co-administered on Day 4.
干预措施: Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG) (Drug)
结局指标
主要结局
Cmax
时间窗: From the start of Period 1 to completion of Period 2 (16 days)
Maximum observed concentration of drug in plasma
AUC0-t
时间窗: From the start of Period 1 to completion of Period 2 (16 days)
Area Under the Plasma Concentration-Time Profile
AUC0-inf
时间窗: From the start of Period 1 to completion of Period 2 (16 days)
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time
次要结局
- Number of Participants with Adverse Events (AEs)(Up to 58 days)
- Number of Participants With Clinically Significant Change in Vital Signs(Up to 44 days)
- Number of Participants With Clinically Significant Change in Clinical Laboratory Evaluations(Up to 44 days)
- Number of Participants With Clinically Significant Change in Electrocardiogram(Up to 40 days)
- Number of Participants With Clinically Significant Change to the Physical Examination(Screening (Day -28))