Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Conditions
Brief summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants.
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
DRUGVX-407
Solution or Suspension for oral administration.
DRUGPlacebo
Solution or Suspension for oral administration.
DRUGMidazolam
Syrup for oral administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * A total body weight of greater than (\>) 50 kg * Nonsmoker or ex-smoker for at least 3 months before screening Key
Exclusion criteria
* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * Any condition possibly affecting drug absorption Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Enrollment up to Day 10 |
| Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Enrollment up to Day 23 |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407 | From Day 1 up to Day 6 |
| Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407 | Days 1, 7, and 14 |
| Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407 | On Day 1, and Day 15 |
| Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407 | On Day 1, and Day 15 |
| Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Enrollment up to Day 24 |
| Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407 | From Day 1 up to Day 6 |
| Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 Under Fasted Conditions | Days 1, 7, and 13 |
| Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation Under Fed versus Fasted State | Days 1, 7, and 13 |
| Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 Tablet Formulation Under Fed versus Fasted State | Days 1, 7, and 13 |
| Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Enrollment up to Day 22 |
| Part D: Maximum Observed Plasma Concentration (Cmax) of VX-407 Tablet Formulation (test) compared to a Suspension Formulation (reference) Under Fasted Conditions | Days 1, 7, and 13 |
| Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407 | Days 1, 7, and 14 |
Countries
Canada, United States
Outcome results
None listed