NCT06154447

Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis

A Phase 1, Study of VX-828 in Healthy Subjects and in Subjects With Cystic Fibrosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 255 (estimated)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics of VX-828 and VX-828 in triple combination (TC) with Tezacaftor (TEZ)/ VX-118 or TEZ/ deutivacaftor (D-IVA) in healthy participants and VX-828 in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).

Detailed description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VX-828	Suspension for Oral Administration
DRUG	Placebo	Suspension for Oral Administration
DRUG	Itraconazole	Solution for Oral Administration
DRUG	Midazolam	Syrup for Oral Administration
DRUG	Tezacaftor	Tablets for Oral Administration
DRUG	VX-118	Tablets for Oral Administration
DRUG	Placebo	Suspension and Tablets for Oral Administration
DRUG	Deutivacaftor	Tablets for Oral Administration
DRUG	VX-828	Tablets for Oral Administration

Timeline

• Start date: 2023-12-12
• Primary completion: 2026-04-23
• Completion: 2026-04-23
• First posted: 2023-12-04
• Last updated: 2026-04-14

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study