Status:
COMPLETED
A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 he...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03486236
Start Date
July 20 2016
End Date
September 14 2016
Last Update
April 3 2018
Active Locations (1)
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1
The Medicines Evaluation Unit
Manchester, United Kingdom