NCT03768089

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

A Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

• Cystic Fibrosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-03-20
• Primary completion: 2019-05-03
• Completion: 2019-05-03
• First posted: 2018-12-07
• Last updated: 2022-07-14
• Results posted: 2022-07-14

Locations

7 sites across 2 countries: Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study