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

Vertex Pharmaceuticals Incorporated16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

VX-440DRUG

VX-440 was administered in TC with TEZ and IVA.

TEZDRUG

TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA)

IVADRUG

IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Medicines Evaluation Unit

Manchester, United Kingdom

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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

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

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

Data from ClinicalTrials.gov

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