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

NCT07283770 · tracked via the Priya Life Science USA tracker

Sponsor

Vertex Pharmaceuticals Incorporated

Phase

Phase 1

Started

2025-12-09

Last updated

2026-07-16

Condition(s) studied

Cystic Fibrosis

Investigational drug(s) / intervention(s)

VX-581PlaceboD-IVATEZ

VX-581: Suspension for Oral Administration.

Placebo: Suspension for Oral Administration.

D-IVA: Tablet for Oral Administration.

TEZ: Tablet for Oral Administration.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 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) — 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) — From Day -1 up to Day 17

Trial sites (1)

Facility	City	Region	Status
Altasciences - Kansas City	Overland Park	Kansas	Recruiting

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Other trials for the same condition

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy Active, not recruiting

Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis Recruiting

Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older Enrolling by invitation

Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants Recruiting

A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07283770 on ClinicalTrials.gov ↗ ← All trials in the USA