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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003048-35 | EudraCT Number |
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Evaluate the safety and tolerability of VX-659 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: VX-659 or Matching Placebo | Experimental | Part A includes single-dose escalation. |
|
| Part B: VX-659 or Matching Placebo | Experimental | Part B includes multiple-dose escalation. |
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| Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo | Experimental | Part C includes multiple dose escalation of VX-659 administered in Triple Combination (TC). |
|
| Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo | Experimental | Part D includes subjects with CF. Participants will receive TC or matching placebos. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-659 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability assessments as determined by number of subjects with adverse events (AEs) and serious adverse events (SAEs) | from baseline up to Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of VX-659 and selected metabolites (μg/mL) | from baseline up to Day 18 | |
| Cmax of TEZ and selected metabolites (μg/mL) | from baseline up to Day 18 | |
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Inclusion Criteria:
Healthy Volunteers: PARTS A, B, and C
CF Patients: PART D
Exclusion Criteria:
Healthy Volunteers: PARTS A, B, and C
CF Patients: PART D
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | United Kingdom | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37983082 | Derived | Heneghan M, Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2023 Nov 20;11(11):CD010966. doi: 10.1002/14651858.CD010966.pub4. | |
| 33331662 | Derived |
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| Tezacaftor | Drug |
|
|
| Ivacaftor | Drug |
|
|
| VX-659 Matching Placebo | Drug |
|
| Triple Combination (TC) Matching Placebos | Drug |
|
| Cmax of IVA and selected metabolites (μg/mL) |
| from baseline up to Day 18 |
| Area under the concentration versus time curve during a dosing interval (AUCtau) of VX-659 and selected metabolites (μg,h/mL) | from baseline up to Day 18 |
| AUCtau of TEZ and selected metabolites (μg,h/mL) | from baseline up to Day 18 |
| AUCtau of IVA and selected metabolites (μg,h/mL) | from baseline up to Day 18 |
| Observed pre-dose concentration (Ctrough) of VX-659 and selected metabolites (μg/mL) | from baseline up to Day 18 |
| Ctrough of TEZ and selected metabolites (μg/mL) | from baseline up to Day 18 |
| Ctrough of IVA and selected metabolites (μg/mL) | from baseline up to Day 18 |
| Cambridge |
| United Kingdom |
| Exeter | United Kingdom |
| Glasgow | United Kingdom |
| Leeds | United Kingdom |
| Liverpool | United Kingdom |
| London | United Kingdom |
| Manchester | United Kingdom |
| Newcastle upon Tyne | United Kingdom |
| Southampton | United Kingdom |
| Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3. |
| 30334693 | Derived | Davies JC, Moskowitz SM, Brown C, Horsley A, Mall MA, McKone EF, Plant BJ, Prais D, Ramsey BW, Taylor-Cousar JL, Tullis E, Uluer A, McKee CM, Robertson S, Shilling RA, Simard C, Van Goor F, Waltz D, Xuan F, Young T, Rowe SM; VX16-659-101 Study Group. VX-659-Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis and One or Two Phe508del Alleles. N Engl J Med. 2018 Oct 25;379(17):1599-1611. doi: 10.1056/NEJMoa1807119. Epub 2018 Oct 18. |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| C000629057 | VX-659 |
| C000625213 | tezacaftor |
| C545203 | ivacaftor |
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