NCT06312787CompletedPhase 1
A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet Formulation
A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-118 in Healthy Adult Subjects
Source: ClinicalTrials.gov · Last updated 3 Jun 2024
Brief summary (registry, in English)
The purpose of this study is to evaluate the relative bioavailability, effect of food on the pharmacokinetic parameters, and safety and tolerability, of a tablet formulation of VX-118 in healthy participants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 8 Mar 2024
- Start date
- Apr 2024
- Primary completion date
- May 2024
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Diseases
- Cystic fibrosis
- NCT number
- NCT06312787
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 15
- From Apr 2024 to the primary completion date, May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
- Hypersensitivity to any component of the investigational drug product
- Other protocol defined Inclusion/Exclusion criteria may apply.
Other illness
- Any condition possibly affecting drug absorption
Who the study is looking for
- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2), both inclusive
- A total body weight greater than (\>) 50 kg
- Participants of non-childbearing potential
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Celerion, Lincoln Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.