Trials / Terminated
TerminatedNCT03633526
Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-659/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 6 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects with F/F or F/MF genotypes. The study was discontinued after completion of Part A due to Sponsor's discretion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VX-659/TEZ/IVA | VX-659/TEZ/IVA FDC tablet. |
| DRUG | IVA | IVA mono tablet. |
Timeline
- Start date
- 2018-08-03
- Primary completion
- 2019-01-18
- Completion
- 2019-01-18
- First posted
- 2018-08-16
- Last updated
- 2020-02-05
- Results posted
- 2020-02-05
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03633526. Inclusion in this directory is not an endorsement.