Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
114 participants
INTERVENTIONAL
2023-02-08
2024-02-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 1, First-in-human Study of VX-634
NCT05579431
Efficacy/Safety of HA Inhalation Solution for Hereditary Emphysema in Patients With Alpha-1 Antitrypsin Deficiency
NCT03114020
Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)
NCT01983241
Safety, Efficacy and Pharmacokinetics of C21 in Subjects With IPF
NCT04533022
Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19
NCT05387239
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A
Participants grouped in different cohorts will receive a single ascending dose of VX-668.
VX-668
Suspension for oral administration.
Placebo Part A
Participants will be randomized to receive placebo matched to VX-668.
Placebo
Suspension for oral administration.
Part B
Participants grouped in different cohorts will receive multiple doses of VX-668.The dose levels will be determined based on the data from Part A.
VX-668
Suspension for oral administration.
Placebo Part B
Participants will be randomized to receive placebo matched to VX-668.
Placebo
Suspension for oral administration.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VX-668
Suspension for oral administration.
Placebo
Suspension for oral administration.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Females of childbearing potential
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Celerion - Tempe
Tempe, Arizona, United States
University of Florida
Gainesville, Florida, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States
ICON Lenexa
Lenexa, Kansas, United States
ICON Salt Lake City
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VX22-668-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.