A Phase 1, Study of VX-828 in Healthy Subjects and in Subjects With Cystic Fibrosis
Vertex Pharmaceuticals Incorporated
Summary
The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics of VX-828 and VX-828 in triple combination (TC) with Tezacaftor (TEZ)/ VX-118 or TEZ/ deutivacaftor (D-IVA) in healthy participants and VX-828 in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).
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.).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Key Inclusion Criteria: Parts A-D: * Participants between the ages of 18 and 55 years * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * A total body weight of more than (\>) 50 kg * Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening * Cohort C2 only: Willing to provide a single DNA sample Part E: * Participants 18 years or older * Confirmed diagnosis of CF as determined by the investigator * A total body weight of more than or equal to (\>=) 35 kg * Participants must be h…
Interventions
- DrugVX-828
Suspension for Oral Administration
- DrugPlacebo
Suspension for Oral Administration
- DrugItraconazole
Solution for Oral Administration
- DrugMidazolam
Syrup for Oral Administration
- DrugTezacaftor
Tablets for Oral Administration
- DrugVX-118
Tablets for Oral Administration
- DrugPlacebo
Suspension and Tablets for Oral Administration
Locations (12)
- Joe DiMaggio Cycstic Fibrosis & Pulmonary CenterHollywood, Florida
- AdventHealth Medical Group Pulmonology at Orlando RidgewoodOrlando, Florida
- Altasciences Clinical KansasOverland Park, Kansas
- Kentucky Children's HospitalLexington, Kentucky
- Boston Children's HospitalBoston, Massachusetts
- University of Minnesota -PulmonologyMinneapolis, Minnesota