Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Conditions
Brief summary
The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.
Detailed description
The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives. 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
Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m\^2), inclusive * A total body weight of greater than (\>) 50 kg Key
Exclusion criteria
* History of febrile illness within 5 days before the first dose of study drug * Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Maximum Observed Plasma Concentration (Cmax) of LNG/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): Maximum Observed Plasma Concentration (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 C (Optional): Maximum Observed Plasma Concentration (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 D (Optional): Maximum Observed Plasma Concentration (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 A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG/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): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) 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 C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (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): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (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 39 |
| 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: Maximum Observed Plasma Concentration (Cmax) of VX-407 | Days 9, 15 and 21 up to Day 27 |
| Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407 | Days 11, 17 and 23 up to Day 31 |
| Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407 | Days 7, 13 and 19 up to Day 23 |
| Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407 | Days 9, 15 and 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 VX-407 | Days 9, 15 and 21 up to Day 27 |
| Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 | Days 11, 17 and 23 up to Day 31 |
| Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 | Days 7, 13 and 19 up to Day 23 |
| Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 | Days 9, 15 and 21 up to Day 27 |
Contacts
CONTACTMedical Information
Outcome results
None listed