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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03486236 |
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Date of registration:
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27/03/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects
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Scientific title:
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A Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With VX-661/Ivacaftor in Healthy Adult Subjects |
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Date of first enrolment:
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July 20, 2016 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03486236 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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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 =80% of their predicted value at
screening.
Exclusion Criteria:
- For female subjects: Pregnant or nursing subjects.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- History of hemolysis.
- Total bilirubin level >2 × ULN at Screening.
Other protocol defined Inclusion/Exclusion criteria applied.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: IVA
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Drug: Matched Placebos
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Drug: VX-440
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Drug: TEZ
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Primary Outcome(s)
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Safety and tolerability were based on the number and assessment of adverse events (AEs) and serious adverse events (SAEs)
[Time Frame: from baseline through safety follow-up visit (up to 29 days)]
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Secondary Outcome(s)
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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)
[Time Frame: from Day 1 through Day 18]
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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)
[Time Frame: from Day 1 through Day 18]
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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)
[Time Frame: from Day 1 through Day 18]
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Secondary ID(s)
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2016-000762-38
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VX16-440-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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