Trials / Completed
CompletedNCT03911713
A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VX-561 | VX-561 tablets for oral administration. |
| DRUG | IVA | 150-mg film-coated tablet for oral administration. |
| DRUG | Placebo | Placebo matched to IVA. |
| DRUG | Placebo | Placebos matched to VX-561. |
Timeline
- Start date
- 2019-04-17
- Primary completion
- 2020-08-20
- Completion
- 2020-08-20
- First posted
- 2019-04-11
- Last updated
- 2022-01-25
- Results posted
- 2022-01-25
Locations
48 sites across 7 countries: United States, Australia, Belgium, Germany, Ireland, Netherlands, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03911713. Inclusion in this directory is not an endorsement.