A Phase 1, Open-Label Study to Evaluate the Effect of Elenestinib on the Pharmacokinetics of Midazolam and Combined Oral Contraceptives, Levonorgestrel/Ethinyl Estradiol, in Healthy Adult Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t)
研究概览
简要总结
The main objectives of this study are to determine the effect of elenestinib on the pharmacokinetic parameters (how the drug is absorbed, distributed, and processed by the body) of midazolam, and to determine the effect of elenestinib on the pharmacokinetic parameters of levonorgestrel/ethinyl estradiol, when given as a combined oral contraceptive.
Healthy adult participants will receive midazolam and levonorgestrel/ethinyl estradiol with and without elenestinib and have blood samples taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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, adult, female, 18-65 years of age, inclusive, at the screening visit that meet either of the following criteria:
- •Postmenopausal female, defined as amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status at the screening visit (note that participants may have had hysterectomy, bilateral salpingectomy, or bilateral tubal ligation).
- •Female status-post bilateral oophorectomy.
- •Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 6 months prior to the first dosing.
- •BMI ≥ 18.0 and ≤ 35.0 kg/m2 at the screening visit.
- •Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.
排除标准
- •History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- •History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- •History or presence of alcohol or drug abuse (except for the occasional use of cannabis products) within the past 1 years prior to the first dosing.
- •History or presence of cannabis use within the past 3 months prior to the first dosing.
- •History or presence of hypersensitivity or idiosyncratic reaction to elenestinib, midazolam, combined oral contraceptive (levonorgestrel/ethinyl estradiol), or related compounds.
- •Unable to refrain from or anticipates the use of:
- •Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing.
- •Any drugs known to be moderate or strong inducers of CYP3A4 enzymes and/or P-gp beginning at least 28 days prior to first dosing.
- •Any drugs known to increase or decrease levels of SHBG, including any oral, topical, or intravaginal hormone-containing product, within 12 weeks prior to the first dosing.
- •Other protocol-defined inclusion and exclusion criteria apply.
研究组 & 干预措施
Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol
干预措施: Elenestinib (Drug)
Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol
干预措施: Midazolam (Drug)
Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol
干预措施: Levonorgestrel/Ethinyl Estradiol (Drug)
结局指标
主要结局
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t)
时间窗: Up to 27 days
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
时间窗: Up to 27 days
Percent of AUC0-inf extrapolated (AUC%extrap)
时间窗: Up to 27 days
Maximum observed concentration (Cmax)
时间窗: Up to 27 days
Time to reach Cmax (Tmax)
时间窗: Up to 27 days
Apparent first-order terminal elimination half-life (t1/2)
时间窗: Up to 27 days
Apparent total plasma clearance after oral administration (CL/F)
时间窗: Up to 27 days
Apparent volume of distribution during the terminal elimination phase after oral administration (Vz/F)
时间窗: Up to 27 days
次要结局
- Number of participants with treatment-emergent adverse events (TEAEs)(From first dose to date of last dose plus 30 days (up to approximately 7 weeks))