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

NCT ID: NCT07283770

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-09

Study Completion Date

2026-11-19

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581.

Detailed Description

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The study is being conducted to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581 in healthy participants and consists of Screening Phase, Treatment Phase and Safety Follow-up Phase. Note: 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

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: Single Ascending Dose

Participants will be randomized to receive a single dose of VX-581.

Group Type EXPERIMENTAL

VX-581

Intervention Type DRUG

Suspension for Oral Administration.

Placebo: Part A

Participants will be randomized to receive a single dose of placebo matched to VX-581.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Suspension for Oral Administration.

Part B: Multiple Ascending Dose

Participants will be randomized to receive multiple doses of VX-581.

Group Type EXPERIMENTAL

VX-581

Intervention Type DRUG

Suspension for Oral Administration.

Placebo: Part B

Participants will be randomized to receive multiple doses of placebo matched to VX-581.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Suspension for Oral Administration.

Interventions

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VX-581

Suspension for Oral Administration.

Intervention Type DRUG

Placebo

Suspension for Oral Administration.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>) 50 kg
* Male and Female participants of non-childbearing potential

Exclusion Criteria

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Altasciences - Kansas City

Overland Park, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Medical Information

Role: CONTACT

Phone: 617-341-6777

Email: [email protected]

Other Identifiers

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VX25-581-001

Identifier Type: -

Identifier Source: org_study_id