A PHASE 1, OPEN LABEL, FIXED SEQUENCE STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06650833 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
- 10
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration for Levonorgestrel
研究概览
简要总结
This is a Phase 1, open label, fixed sequence study of the effect of multiple dose PF-06650833 on single dose OC PK in healthy female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
- •Healthy female subjects
- •Female subjects of non childbearing potential must meet at least 1 of the following criteria:
- •Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;
- •Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- •Have medically confirmed ovarian failure.
- •All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential and will be eligible with adequate contraceptive usage.
- •Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
排除标准
- •Subjects with any of the following characteristics/conditions will not be included in the study:
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
- •Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- •Any current evidence of untreated active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
- •History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing
- •Benign ethnic (cyclic) neutropenia.
研究组 & 干预措施
OC only
Subjects will receive a single dose of an oral contraceptive during the first period of the study
干预措施: Ethinyl estradiol (EE) and levonogestrel (LN) (Drug)
PF-06650833 + OC
Subjects will receive PF-06650833 every day for 11 days and a single dose of an oral contraceptive on day 10.
干预措施: PF-06650833 (Drug)
PF-06650833 + OC
Subjects will receive PF-06650833 every day for 11 days and a single dose of an oral contraceptive on day 10.
干预措施: Ethinyl estradiol (EE) and levonogestrel (LN) (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration for Levonorgestrel
时间窗: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for LN was determined using linear/Log trapezoidal method.
Maximum Plasma Concentration (Cmax) for Ethinyl Estradiol
时间窗: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
Cmax was defined as maximum plasma concentration. Cmax for EE was observed directly from data.
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Ethinyl Estradiol
时间窗: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for EE was determined using linear/Log trapezoidal method.
Maximum Plasma Concentration for Levonorgestrel
时间窗: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post OC dose in Periods 1 and 2
Cmas was defined as maximum plasma concentration. Cmax for LN was observed directly from data.
次要结局
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events(From the first dose up to 35 days after the last dose of study intervention)
- Number of Participants With Treatment Emergent Adverse Events by Severity(From the first dose up to 35 days after the last dose of study intervention)
- Number of Participants With Categorical Vital Signs Data of Potential Clinical Concern(Day 1 for Period 1 and Day 1, Day 10, Day 12 for Period 2)
- Number of Participants With Laboratory Abnormalities of Potential Clinical Concern(Day 10, Day 12 for Period 2)