APOL1-mediated Kidney Disease
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and PK of single and multiple ascending doses of VX-840 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-840
Solution for oral administration.
DRUGPlacebo
Placebo matched to VX-840 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: * Female participants must be of non-childbearing potential * Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m\^2) * A total body weight greater than (\>) 50 kg Key
Exclusion criteria
* History of febrile illness or other acute illness 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 |
|---|---|
| Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to Day 25 |
Secondary
| Measure | Time frame |
|---|---|
| Parts A and B: Plasma Concentration of VX-840 Over Time | From Day 1 up to Day 14 |
| Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity [AUC(0 - inf)] | From Day 1 up to Day 14 |
| Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration [AUC(0-tlast)] | From Day 1 up to Day 14 |
| Part B: Amount of VX-840 Excreted in the Urine During the Dosing Interval (Ae) | From Day 1 up to Day 14 |
| Part B: Associated Renal Clearance (CLr) of VX-840 | From Day 1 up to Day 14 |
Countries
United States
Outcome results
None listed