Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants

← catalyst calendar

NCT07283770 · readout in 91 d

Sponsored by Vertex Pharmaceuticals Incorporated (industry) · VRTX — their whole pipeline →.

Phase

Phase 1

Status

Recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

136estimated

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-12-09

actual

When the study began enrolling

Primary completion

2026-11-19

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2026-11-19

estimated

The whole study's end, after follow-up

First posted

2025-12-16

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-16

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Cystic Fibrosis

Interventions

Drug: VX-581
Drug: Placebo
Drug: D-IVA — also filed as deutivacaftor
Drug: TEZ — also filed as tezacaftor

Primary outcomes

what the primary-completion date above is the date OF

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

measured From Day -1 up to Day 8

Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

measured From Day -1 up to Day 17

Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

measured From Day -1 up to Day 17

Permalink · VRTX's whole pipeline · Catalyst calendar · Every registered study · What changed