A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06700841 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
- 18
- 试验地点
- 2
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN
研究概览
简要总结
This Phase 1 study will assess the pharmacokinetic effect of multiple doses PF 06700841 (administered once a day) on a single dose of a combination oral contraceptive, in 18 healthy female participants who are not of childbearing potential.
详细描述
This is a Phase 1, randomized, 2 way crossover, multiple-dose, open label study of the effect of multiple doses PF-06700841 on single dose combination oral contraceptive (OC) pharmacokinetics (PK) in healthy female participants aged 18-60.
The study consists of a screening phase (up to 28 days prior to Day 1); two treatment periods during which participants are resident in the Clinical Research Unit (CRU) and a final follow-up telephone contact, which will be conducted after 28-35 following administration of the last dose.
Participants will be randomized to 1 of 2 treatment sequences. A total of 18 healthy female participants (9 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods in a single fixed sequence. Participants will be screened within 28 days of the first dose of investigational product. Participants will report to the Clinical Research Unit (CRU) the day prior to Day 1 dosing in Period 1 for both treatment sequences, and will report to the CRU the day prior to Day 1 dosing in Period 2 for Treatment Sequence 2. In Treatment Sequence 1, participants will remain in the CRU for up to 21 days and 20 nights. There will be no washout period in Treatment Sequence 1. In Treatment Sequence 2, participants will remain in the CRU for up to 22 days and 20 nights. Participants in treatment sequence 2 will have an outpatient washout period of at least 10 days between Period 1 and Period 2. A single administration of OC in the form of 1 PORTIA or equivalent tablet will be administered in one of the two periods (reference treatment) and in the alternative treatment period, daily doses of 60 mg PF-06700841 will be administered for 13 days with a single dose of OC being administered on Day 10. PK (AUCinf, Cmax, AUClast, Tmax and t½) of OC will then be assessed at pre OC dose and over 96 hours, post OC dosing.
Safety assessments will be conducted at the CRU.
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
- •Healthy females aged 18-60
- •Not of childbearing potential
- •Body mass index of 17.5-30.5 kg/m2
- •Body weight > 50 kg
- •Capable of giving signed informed consent
排除标准
- •Evidence or history of clinically significant disease including irritable bowel disease; HIV; Hep B and Hep C; acute or chronic infection history; lymphoproliferative disorder; tuberculosis; hearing loss; sensitivity to heparin or heparin-induced thrombocytopenia
- •Any condition affecting drug absorption
- •Participants who have experienced major trauma or surgery in the 3 months prior to baseline
- •Participants in imminent need for surgery
- •Use of prescription or non-prescription drugs within 7 days or 5 half-lives prior to dosing
- •Previous administration with an investigational drug within 30 days or 5 half-lives prior to dosing
- •A positive urine drug test
- •Hypertension
- •ECG anomalies
- •Significant laboratory anomalies
- •History of drug abuse with less than 6 months of abstinence prior to the baseline visit
- •History of alcohol abuse within 6 months of screening
- •History of nicotine use within 30 days of baseline visit
- •Any contraindications to OC
- •History of discontinued use of OC for medical reasons
- •Febrile illness within 5 days prior to dosing
- •Vaccination with live or attenuated virus or live viral components within 6 weeks prior to dosing
- •History of major organ transplant
- •History of severe allergic or anaphylactic reaction to kinase inhibitors
- •have donated blood of 500mL or more within 60 days prior to dosing
研究组 & 干预措施
Sequence 1
In 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-06700841 PO for 13 days with a single dose of OC administered on the morning of day 10.
干预措施: PF-06700841 (Drug)
Sequence 1
In 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-06700841 PO for 13 days with a single dose of OC administered on the morning of day 10.
干预措施: Ethinyl estradiol (EE) and levonorgestrel (LN) (Drug)
Sequence 2
In sequence 2, period 1, participants will receive PF-06700841 PO for 13 days with a single dose of OC administered on the morning of day 10. After a wash-out period of at least 10 days, participants will continue into period 2 where they will receive an additional single dose of OC.
干预措施: PF-06700841 (Drug)
Sequence 2
In sequence 2, period 1, participants will receive PF-06700841 PO for 13 days with a single dose of OC administered on the morning of day 10. After a wash-out period of at least 10 days, participants will continue into period 2 where they 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 LN
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in periods 1 and 2
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in periods 1 and 2
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
次要结局
未报告次要终点