A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis
NCT03912233 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87
Last updated 2023-04-20
Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis (CF).
Conditions
Interventions
- DRUG
-
VX-121
Tablets for oral administration.
- DRUG
-
TEZ
TEZ tablet for oral administration.
- DRUG
-
VX-561
Tablets for oral administration.
- DRUG
-
TEZ/IVA
Fixed-dose combination tablets for oral administration.
- DRUG
-
IVA
Tablets for oral administration.
- DRUG
-
Placebos matched to VX-121, TEZ, and VX-561 for oral administration.
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-30
- Primary Completion
- 2019-12-10
- Completion
- 2019-12-10
- FDA Drug
- Yes
Countries
- United States
- Germany
- Netherlands
- Portugal
- United Kingdom
Study Locations
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