MedTrace Logo

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

NCT03486236 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-04-03

No results posted yet for this study

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

Conditions

Interventions

DRUG

VX-440

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

DRUG

TEZ

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

DRUG

IVA

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

DRUG

Matched Placebos

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-20
Primary Completion
2016-09-14
Completion
2016-09-14
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03486236 on ClinicalTrials.gov