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NCT07283770PHASE1RecruitingAccepts Healthy Volunteers

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

Vertex Pharmaceuticals Incorporated

Start Date

12/9/2025

Completion Date

11/19/2026

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 for up to ten days.

Detailed Description

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. Additionally, VX-581 will also be administered in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA for up to ten days. 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.).

Eligibility Criteria

Age Range: 18 years to 55 years

Key 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 Key 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 Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

VX-581

DRUG

Placebo

DRUG

D-IVA

DRUG

TEZ

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Conditions

Cystic Fibrosis

Locations

Altasciences - Kansas City

Overland Park, Kansas 66212

United States