Phase 1, Open-label Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Part A: Maximum Observed Plasma Concentration (Cmax) of LNG and EE in the Absence and Presence of VX-407
研究概览
简要总结
The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE, norethindrone (NET) and EE and drospirenone (DRSP) and EE. Also, to evaluate the safety and tolerability of co-administration of VX-407 with LNG/EE, NGM/EE, NET/EE and DRSP/EE.
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m^2)
- •A total body weight of greater than (>) 50 kg
- •Nonsmoker or ex-smoker for at least 12 months before screening
- •Oral contraceptive naïve or able to comply with 28-day or 5 half-lives (whichever is greater) washout before the start of Period 1 (6-month washout for Depo-Provera)
排除标准
- •History of febrile illness within 5 days before the first dose of study drug
- •Relative contraindications to hormonal estrogen therapy that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant
- •Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
- •Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug
- •Menopausal, post-menopausal, or documented bilateral oophorectomy and/or hysterectomy
- •Previously received study drug in this study
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE)
Participants will receive a single dose of LNG/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 every 12 hours (q12h) from Days 8 through 26 in fasted state.
干预措施: VX-407 (Drug)
Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE)
Participants will receive a single dose of LNG/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 every 12 hours (q12h) from Days 8 through 26 in fasted state.
干预措施: LNG/EE (Drug)
Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE)
Participants will receive a single dose of NGM/EE on Days 1 and 23 in fasted state. Participants will also receive VX-407 q12h from Days 10 through 30 in fasted state.
干预措施: VX-407 (Drug)
Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE)
Participants will receive a single dose of NGM/EE on Days 1 and 23 in fasted state. Participants will also receive VX-407 q12h from Days 10 through 30 in fasted state.
干预措施: NGM/EE (Drug)
Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE)
Participants will receive a single dose of NET/EE on Days 1 and 19 in fasted state. Participants will also receive VX-407 q12h from Days 6 through 22 in fasted state.
干预措施: VX-407 (Drug)
Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE)
Participants will receive a single dose of NET/EE on Days 1 and 19 in fasted state. Participants will also receive VX-407 q12h from Days 6 through 22 in fasted state.
干预措施: NET/EE (Drug)
Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE)
Participants will receive a single dose of DRSP/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 q12h from Days 8 through 26 in fasted state.
干预措施: VX-407 (Drug)
Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE)
Participants will receive a single dose of DRSP/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 q12h from Days 8 through 26 in fasted state.
干预措施: DRSP/EE (Drug)
结局指标
主要结局
Part A: Maximum Observed Plasma Concentration (Cmax) of LNG and EE in the Absence and Presence of VX-407
时间窗: From Day 1 up to Day 7 and Day 21 up to Day 27
Part D (Optional): AUC0-inf of DRSP and EE in the Absence and Presence of VX-407
时间窗: From Day 1 up to Day 7 and Day 21 up to Day 27
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG and EE in the Absence and Presence of VX-407
时间窗: From Day 1 up to Day 7 and Day 21 up to Day 27
Part B (Optional): AUC0-inf of NGMN and NG (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407
时间窗: From Day 1 up to Day 9 and Day 23 up to Day 31
Part B (Optional): Cmax of Norelgestromin (NGMN) and Norgestrel (NG) (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407
时间窗: From Day 1 up to Day 9 and Day 23 up to Day 31
Part D (Optional): Cmax of DRSP and EE in the Absence and Presence of VX-407
时间窗: From Day 1 up to Day 7 and Day 21 up to Day 27
Part C (Optional): Cmax of NET and EE in the Absence and Presence of VX-407
时间窗: From Day 1 up to Day 5 and Day 19 up to Day 23
Part C (Optional): AUC0-inf of NET and EE in the Absence and Presence of VX-407
时间窗: From Day 1 up to Day 5 and Day 19 up to Day 23
次要结局
- Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 36)
- Part B (Optional): Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 40)
- Part C (Optional): Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 32)
- Part D (Optional): Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 36)
- Part A: Cmax of VX-407(Days 9, 15 and 21 up to Day 27)
- Part A: AUC0-inf of VX-407(Days 9, 15 and 21 up to Day 27)
- Part B (Optional): Cmax of VX-407(Days 11, 17 and 23 up to Day 31)
- Part B (Optional): AUC0-inf of VX-407(Days 11, 17 and 23 up to Day 31)
- Part C (Optional): Cmax of VX-407(Days 7, 13 and 19 up to Day 23)
- Part C (Optional): AUC0-inf of VX-407(Days 7, 13 and 19 up to Day 23)
- Part D (Optional): Cmax of VX-407(Days 9, 15 and 21 up to Day 27)
- Part D (Optional): AUC0-inf of VX-407(Days 9, 15 and 21 up to Day 27)