A Phase 1, Study of VX-828 in Healthy Subjects and in Subjects With Cystic Fibrosis
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
⁃ 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 heterozygous for F508del with a second CFTR allele carrying a minimal function mutation that is not responsive to ELX/TEZ/IVA therapy
• Participants must have a forced expiratory volume in 1 second (FEV1) of greater than or equal to (≥) 40% of predicted normal for age, sex, and height
Locations
United States
Florida
Joe DiMaggio Cycstic Fibrosis & Pulmonary Center
RECRUITING
Hollywood
Central Florida Pulmonary Group, P.A.
RECRUITING
Orlando
Kansas
Altasciences Clinical Kansas
RECRUITING
Overland Park
Kentucky
Kentucky Children's Hospital
RECRUITING
Lexington
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Minnesota
University of Minnesota -Pulmonology
RECRUITING
Minneapolis
New York
New York Medical College
RECRUITING
Hawthorne
Ohio
ProMedica Toledo Children's Hospital & ProMedica Central Physicians, LLC
RECRUITING
Toledo
Texas
Cook Children's Pulmonology
RECRUITING
Fort Worth
Utah
University of Utah Hospital - Pulmonology
RECRUITING
Salt Lake City
Vermont
Vermont Lung Center
RECRUITING
Colchester
Contact Information
Primary
Medical Information
medicalinfo@vrtx.com
617-341-6777
Time Frame
Start Date:2023-12-12
Estimated Completion Date:2026-04-23
Participants
Target number of participants:255
Treatments
Experimental: Part A: Single Ascending Dose (SAD)
Participants will be randomized to receive a single dose of different dose levels of VX-828.
Placebo_comparator: Part A: Placebo
Participants will be randomized to receive placebo matched to VX-828.
Experimental: Part B: Multiple Ascending Dose (MAD)
Participants will be randomized to receive multiple doses of different dose levels of VX-828. The dose levels will be determined based on the data from Part A.
Placebo_comparator: Part B: Placebo
Participants will be randomized to receive placebo matched to VX-828.
Experimental: Part C: Drug Drug Interaction
Participants will receive a single dose of VX-828, followed by a washout period, Itraconazole administration, and concomitant administration of itraconazole and VX-828; or participants will receive Midazolam followed by VX-828/TEZ/D-IVA administration, and concomitant administration of VX-828/TEZ/D-IVA and Midazolam.~Part C will be an open-label optional cohort.
Experimental: Part D: VX-828 in combination with TEZ/VX-118 ,TEZ/D-IVA or D-IVA
Participants will be randomized to receive VX-828 in combination with TEZ/VX-118, TEZ/D-IVA, or D-IVA.
Placebo_comparator: Part D: Placebo
Participants will be randomized to receive placebo matched to VX-828/TEZ/VX-118 or placebo matched to VX-828 in combination with TEZ/D-IVA or D-IVA
Experimental: Part E: VX-828 in Combination with D-IVA with or without TEZ in CF
Participants with cystic fibrosis will receive VX-828 in combination with D-IVA with or without TEZ.