Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the pharmacokinetics and safety of VX-809 and VX-770 alone and in combination in healthy subjects.
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple-dose study of orally administered VX-809 and VX-770 in healthy subjects. This study will evaluate safety and tolerability of VX-809 and VX-770 alone and in combination.
Subjects will be randomized to receive study drug or placebo during three 14-day treatment periods separated by 14-day washout periods. In Treatment Period 1, subjects randomized to study drug will receive VX-809 every 24 hours. In Treatment Period 2, subjects randomized to study drug will receive VX-770 every 12 hours. In Treatment Period 3, subjects will receive VX-809 every 24 hours and VX-770 every 12 hours. Subjects randomized to placebo will receive placebo during all treatment periods.
Enrollment is planned at 1 clinical site (Lenexa, Kansas). Up to 72 subjects will be enrolled. The study will be separated into 3 dose escalation cohorts. Cohort 1 and Cohort 2 will enroll 24 subjects. Cohort 3 is optional and may be conducted after a review of safety and pharmacokinetic data by Vertex.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Subjects randomized to study drug will take VX-809 for 14 days followed by a 14 day washout. Next subjects will take VX-770 for 14 days followed by a 14 day washout. Lastly, subjects will take both VX-809 and VX-770 for 14 days. |
|
| Placebo Arm | Placebo Comparator | Subjects randomized to placebo will take VX-809 placebo for 14 days followed by a 14 day washout. Next subjects will take VX-770 placebo for 14 days followed by a 14 day washout. Lastly, subjects will take both VX-809 and VX-770 placebo for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-809 | Drug | capsule, taken once daily |
| |
| VX-770 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters (including concentration, exposure and half-life) of VX-809 and its metabolite in plasma in the presence and absence of VX 770 | Blood samples drawn during the study will be analyzed to measure the PK parameters, such as concentration, exposure and half-life of VX-809 and its metabolite. | 70 days |
| PK parameters (including concentration, exposure and half-life) of VX-770 and its metabolites in plasma in the presence and absence of VX 809 | Blood samples drawn during the study will be analyzed to measure the PK parameters, such as concentration, exposure and half-life of VX-770 and its metabolites. | 70 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as measured by adverse events (AEs) and clinically significant changes in laboratory values (clinical chemistry, hematology, coagulation, and urinalysis), electrocardiograms, and vital signs | 70 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laurent Vernillet, PharmD, PhD, FCP | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA | Lenexa | Kansas | 66219 | United States |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C569105 | lumacaftor |
| C545203 | ivacaftor |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
tablet, taken once every 12 hours |
|
| VX-809 placebo | Drug | capsule, taken once daily |
|
| VX-770 placebo | Drug | tablet, taken once every 12 hours |
|
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |