A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects
Phase 1
Completed
- Conditions
- Cystic Fibrosis
- Interventions
- Registration Number
- NCT03486236
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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 healthy male and female subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort C1 VX-440 - Cohort C1: Triple Placebo Matched Placebos - Cohort C1 IVA - Cohort C2 TEZ - Cohort C2 IVA - Cohort C2: Triple Placebo Matched Placebos - Cohort C1 TEZ - Cohort C2 VX-440 -
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method 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) 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
Trial Locations
- Locations (1)
The Medicines Evaluation Unit
🇬🇧Manchester, United Kingdom