NCT06380205已完成1 期
A Phase 1, Open-Label Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Levonorgestrel (LNG) concentration in plasma
研究概览
简要总结
The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Ability to comprehend and willingness to sign a written ICF for the study.
- •Females aged 18 to 60 years, inclusive, at the time of signing the ICF.
- •Body mass index between 18.0 and 30.5 kg/m2, inclusive.
- •No clinically significant findings in screening evaluations (eg, clinical, laboratory, and ECG evaluations).
- •Ability to swallow and retain oral medication.
排除标准
- •History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months before screening.
- •Presence or history of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could affect drug absorption.
- •Current or recent (within 3 months before screening) clinically significant gastrointestinal disease (eg, gallbladder disease) or surgery (including cholecystectomy; excluding appendectomy) that could affect the absorption of study treatment.
- •History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease (eg, deep vein thrombosis), pulmonary embolism, or uncontrolled hypertension (ie, blood pressure > 140/90 mmHg at screening, confirmed by repeat testing).
- •Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
- •History of tobacco- or nicotine-containing product-use within 1 month before screening.
- •Pregnant, breastfeeding, or planning to conceive during the study.
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE)
Experimental
Povorcitinib and LNG/EE will be administered at the protocol defined doses.
干预措施: Povorcitinib (Drug)
Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE)
Experimental
Povorcitinib and LNG/EE will be administered at the protocol defined doses.
干预措施: Levonorgestrel/Ethinyl estradiol (Drug)
结局指标
主要结局
Levonorgestrel (LNG) concentration in plasma
时间窗: Up to Day 21
LNG concentration in plasma.
Ethinyl estradiol (EE) concentration in plasma
时间窗: Up to Day 21
EE concentration in plasma.
次要结局
- Number of participants with Treatment-emergent Adverse Events (TEAEs)(Up to Day 32)
- Additional LNG/EE PK parameters in plasma(Up to Day 21)
- Povorcitinib concentration in plasma(Up to Day 21)
研究者
研究点 (1)
Loading locations...
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