A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects
NCT ID: NCT03486236
Last Updated: 2018-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2016-07-20
2016-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort C1
VX-440
VX-440 was administered in TC with TEZ and IVA.
TEZ
TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA)
IVA
IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet
Cohort C1: Triple Placebo
Matched Placebos
Placebos matched to VX-440, TEZ, and IVA.
Cohort C2
VX-440
VX-440 was administered in TC with TEZ and IVA.
TEZ
TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA)
IVA
IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet
Cohort C2: Triple Placebo
Matched Placebos
Placebos matched to VX-440, TEZ, and IVA.
Interventions
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VX-440
VX-440 was administered in TC with TEZ and IVA.
TEZ
TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA)
IVA
IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet
Matched Placebos
Placebos matched to VX-440, TEZ, and IVA.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 ≥80% of their predicted value at screening.
Exclusion Criteria
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* History of hemolysis.
* Total bilirubin level \>2 × ULN at Screening.
18 Years
55 Years
ALL
Yes
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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The Medicines Evaluation Unit
Manchester, , United Kingdom
Countries
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Other Identifiers
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2016-000762-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX16-440-002
Identifier Type: -
Identifier Source: org_study_id
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