NCT03486236

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

• Cystic Fibrosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-07-20
• Primary completion: 2016-09-14
• Completion: 2016-09-14
• First posted: 2018-04-03
• Last updated: 2018-04-03

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study