Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07283770
PHASE1

Evaluation of VX-581 in Healthy Participants and in Participants With Cystic Fibrosis

Sponsor: Vertex Pharmaceuticals Incorporated

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single dose of VX-581 and multiple ascending doses of VX-581 alone and in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA in healthy participants. The study will also evaluate the safety, tolerability, and pharmacokinetics of VX-581 administered in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).

Official title: A Phase 1 Study of VX-581 in Healthy Subjects and in Subjects With Cystic Fibrosis

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2025-12-09

Completion Date

2027-07-12

Last Updated

2026-10-19

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

VX-581

Suspension for Oral Administration.

DRUG

Placebo

Suspension for Oral Administration.

DRUG

D-IVA

Tablet for Oral Administration.

DRUG

TEZ

Tablet for Oral Administration.

DRUG

ELX/TEZ/IVA

Fixed dose combination (FDC) Tablets for Oral Administration.

DRUG

VX-581

Tablets for Oral Administration.

DRUG

IVA

Tablet for Oral Administration.

Locations (1)

Altasciences - Kansas City

Overland Park, Kansas, United States