MedTrace Logo

Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis

NCT03768089 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2022-07-14

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy subjects and in subjects with cystic fibrosis (CF).

Conditions

Interventions

DRUG

Placebo (matched to VX-121 suspension)

Placebo matched to VX-121 suspension for oral administration.

DRUG

VX-121 (Suspension)

Suspension for oral administration.

DRUG

TEZ/IVA

Fixed-dose combination tablet for oral administration.

DRUG

IVA

Tablet for oral administration.

DRUG

Placebo (matched to TEZ/IVA)

Placebo matched to TEZ/IVA for oral administration.

DRUG

Placebo (matched to IVA)

Placebo matched to IVA for oral administration.

DRUG

VX-121 (Tablet)

Tablet for oral administration.

DRUG

Placebo (matched to VX-121 tablet)

Placebo matched to VX-121 tablet for oral administration.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2019-05-03
Completion
2019-05-03
FDA Drug
Yes

Countries

  • Netherlands
  • 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 NCT03768089 on ClinicalTrials.gov