Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Conditions
Keywords
Oral contraceptives, Drug interaction, Pharmacokinetics
Brief summary
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.
Detailed description
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.).
Interventions
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Maximum Observed Plasma Concentration (Cmax) of LNG and EE in the Absence and Presence of VX-407 | 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 | From Day 1 up to Day 7 and Day 21 up to Day 27 |
| Part B (Optional): Cmax of Norelgestromin (NGMN) and Norgestrel (NG) (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407 | From Day 1 up to Day 9 and Day 23 up to Day 31 |
| Part B (Optional): AUC0-inf of NGMN and NG (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407 | From Day 1 up to Day 9 and Day 23 up to Day 31 |
| Part C (Optional): Cmax of NET and EE in the Absence and Presence of VX-407 | 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 | From Day 1 up to Day 5 and Day 19 up to Day 23 |
| Part D (Optional): Cmax of DRSP and EE in the Absence and Presence of VX-407 | 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 | From Day 1 up to Day 7 and Day 21 up to Day 27 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed