NCT06299709CompletedPhase 1
A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)
A Phase 1, Randomized, Open-Label, 2-part Study to Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor in Combination With Tezacaftor and Deutivacaftor in Healthy Adult Subjects
Source: ClinicalTrials.gov · Last updated 26 Sept 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 29 Feb 2024
- Start date
- 13 Mar 2024
- Primary completion date
- 23 May 2024
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Diseases
- Cystic fibrosis
- NCT number
- NCT06299709
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 34
- From 13 Mar 2024 to the primary completion date, 23 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
- Female participants who are pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug
- Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug
- 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
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, Inc. Coordinator of this site? Confirm its status | Tempe | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.