A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) in Healthy Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG
研究概览
简要总结
The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of combined oral contraceptive (COC) (ethinyl estradiol/levonorgestrel) in healthy female participants. This study will last approximately 35 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants are in good general health, as required by the protocol and as determined by Principal Investigator.
- •Body mass index (BMI) from greater than or equal to (≥) 18.5 to less than or equal to ≤ 30 kilogram per square meter (kg/m^2).
- •Adequate organ function, blood and urine tests, as required by the protocol and as determined by Principal Investigator.
排除标准
- •History or presence of clinically significant diseases of the neurological, dermatological, renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal systems or history or presence of clinically significant psychiatric, immunological, endocrine, or metabolic disease as determined by Principal Investigator.
- •Unwilling or unable to comply with the requirements of the protocol.
- •Determined by Principal Investigator to be unsuitable to participate in the study for any other reason.
研究组 & 干预措施
Vimseltinib + Combined Oral Contraceptive (COC)
Day 1 single dose of combined oral contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG]).
Day 4 through 7, Day 11 and Day 14 single daily dose of Vimseltinib. Day 18 coadministration of COC (EE /LNG) with vimseltinib.
干预措施: Vimseltinib (Drug)
Vimseltinib + Combined Oral Contraceptive (COC)
Day 1 single dose of combined oral contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG]).
Day 4 through 7, Day 11 and Day 14 single daily dose of Vimseltinib. Day 18 coadministration of COC (EE /LNG) with vimseltinib.
干预措施: Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG]) (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG
时间窗: Predose up to 72 Hours Post Dose
PK: Area Under the Plasma Concentration-Time Curve from Time 0 up to Time t (AUC0-t), Where t is the Last Time Point at which the Concentration is Above the Lower Limit of Quantification, of EE and LNG
时间窗: Predose up to 72 Hours Post Dose
PK: AUC from Time 0 to Infinity (AUC0-∞) of EE and LNG
时间窗: Predose up to 72 Hours Post Dose
次要结局
- PK: Apparent Systemic Clearance (CL/F) of EE and LNG(Predose up to 72 Hours Post Dose)
- PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of EE and LNG(Predose up to 72 Hours Post Dose)
- PK: Time to Maximum Observed Plasma Concentration (Tmax) of EE and LNG(Predose up to 72 Hours Post Dose)
- PK: Terminal Elimination Phase Half-Life (t1/2) of EE and LNG(Predose up to 72 Hours Post Dose)
- Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Baseline through Day 35)
- Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters(Baseline through Day 21)
- Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs(Baseline through Day 21)