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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000762-38 | EudraCT Number |
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This study evaluated the safety and pharmacokinetics of multiple ascending doses of VX-440 in combination with tezacaftor/ivacaftor (TEZ/IVA) (triple combination [TC]) administered for 13 days to healthy male and female subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort C1 | Experimental |
| |
| Cohort C1: Triple Placebo | Placebo Comparator |
| |
| Cohort C2 | Experimental |
| |
| Cohort C2: Triple Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-440 | Drug | VX-440 was administered in TC with TEZ and IVA. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability were based on the number and assessment of adverse events (AEs) and serious adverse events (SAEs) | from baseline through safety follow-up visit (up to 29 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA) | from Day 1 through Day 18 | |
| Area under the concentration versus time curve during a dosing interval (AUCtau) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria applied.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medicines Evaluation Unit | Manchester | United Kingdom |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000625213 | tezacaftor |
| C545203 | ivacaftor |
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| 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. |
|
| from Day 1 through Day 18 |
| Observed pre-dose concentration (Ctrough) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA) | from Day 1 through Day 18 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |