A PHASE 1, RANDOMIZED, OPEN LABEL, 2 WAY CROSSOVER STUDY TO DEMONSTRATE A LACK OF AN EFFECT OF MULTIPLE DOSE PF 06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE
研究概览
简要总结
This is a Phase 1, randomized, 2 way crossover, open-label study of the effect of multiple-dose PF 06651600 on single-dose oral contraceptive (OC) pharmacokinetics (PK) in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences. A total of 28 healthy female subjects (14 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods.
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
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Age and Sex:
- •Female participants of non childbearing potential who, at the time of screening, are between the ages of 18 and 60 years, inclusive.
- •Female participants who are healthy as determined by medical evaluation including detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12 lead ECG, or clinical laboratory tests.
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, appendectomy).
- •Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first-degree relative with a hereditary immunodeficiency.
- •Infection with hepatitis B or hepatitis C viruses -
研究组 & 干预措施
Sequence 1
In Treatment Sequence 1, period 1, participants will be dosed with a single administration of oral contraceptive (OC). Participants will continue directly into Period 2 where they will receive PF-06651600 PO for 9 days followed by administration of a single dose of OC on the morning of Day 10.
干预措施: PF-06651600 (Drug)
Sequence 1
In Treatment Sequence 1, period 1, participants will be dosed with a single administration of oral contraceptive (OC). Participants will continue directly into Period 2 where they will receive PF-06651600 PO for 9 days followed by administration of a single dose of OC on the morning of Day 10.
干预措施: Ethinyl estradiol (EE) and levonorgestrel(LN) (Drug)
Sequence 2
In Treatment Sequence 2, Period 1, participants will be dosed with PF-06651600 PO QD for 9 days and administered a single dose of OC on the morning of Day 10. After a washout period of at least 10 days, participants will continue into Period 2 and will receive an additional single dose of OC.
干预措施: PF-06651600 (Drug)
Sequence 2
In Treatment Sequence 2, Period 1, participants will be dosed with PF-06651600 PO QD for 9 days and administered a single dose of OC on the morning of Day 10. After a washout period of at least 10 days, participants will continue into Period 2 and will receive an additional single dose of OC.
干预措施: Ethinyl estradiol (EE) and levonorgestrel(LN) (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE
时间窗: predose, 30 minutes and 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in Periods 1 and 2
30 micrograms administered as oral OC combination tablet
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN
时间窗: predose, 30 minutes and 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in Periods 1 and 2
150 micrograms administered as oral OC combination tablet
次要结局
未报告次要终点