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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03486236

Enrollment

Registered

2018-04-03

Start date

2016-07-20

Completion date

2016-09-14

Last updated

2018-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

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

Interventions

DRUGVX-440

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

DRUGTEZ

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

DRUGIVA

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

DRUGMatched Placebos

Placebos matched to VX-440, TEZ, and IVA.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026