Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03486236 | A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects | PHASE1 | COMPLETED | 16 | — | — | Jul 20, 2016 | Sep 14, 2016 | Apr 3, 2018 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Cohort C1 | EXPERIMENTAL | - |
| Cohort C1: Triple Placebo | PLACEBO_COMPARATOR | - |
| Cohort C2 | EXPERIMENTAL | - |
| Cohort C2: Triple Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| VX-440 | DRUG | VX-440 was administered in TC with TEZ and IVA. |
| TEZ | DRUG | TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA) |
| IVA | DRUG | IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet |
| Matched Placebos | DRUG | Placebos matched to VX-440, TEZ, and IVA. |
Inclusion Criteria: * Female subjects of non-childbearing potential only. * Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight \>50 kg. * Normal pulmonary function measurements, defined as forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) both ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 9 | PHASE3 | VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA, VNZ/TEZ/D-IVA, VX-522 mRNA therapy |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719, SION-451, SION-2222, SION-109 |
| BiomX Ltd | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Illumina, Inc. | ILMN | 1 | — | Undisclosed |