A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: Matched Placebos; Drug: VX-440; Drug: TEZ; Drug: IVA

Study type: Interventional

Funder types: Industry

Identifiers

NCT03486236

VX16-440-002

2016-000762-38 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 4 patient groups, including a placebo group

Cohort C1

Experimental group

Treatment:

Drug: IVA

Drug: TEZ

Drug: VX-440

Cohort C1: Triple Placebo

Placebo Comparator group

Treatment:

Drug: Matched Placebos

Cohort C2

Experimental group

Treatment:

Drug: IVA

Drug: TEZ

Drug: VX-440

Cohort C2: Triple Placebo

Placebo Comparator group

Treatment:

Drug: Matched Placebos