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Clinical Trials in the USA / NCT07283770
Recruiting Phase 1

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

NCT07283770 · tracked via the Priya Life Science USA tracker
Sponsor
Vertex Pharmaceuticals Incorporated
Phase
Phase 1
Started
2025-12-09
Last updated
2026-10-19

Condition(s) studied

Cystic Fibrosis

Investigational drug(s) / intervention(s)

VX-581 →PlaceboD-IVA →TEZ →ELX/TEZ/IVA →VX-581 →IVA →

VX-581: Suspension for Oral Administration.

Placebo: Suspension for Oral Administration.

D-IVA: Tablet for Oral Administration.

TEZ: Tablet for Oral Administration.

ELX/TEZ/IVA: Fixed dose combination (FDC) Tablets for Oral Administration.

VX-581: Tablets for Oral Administration.

IVA: 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 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Key Inclusion Criteria: * Parts A, B, C: * 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 * Part D: * Confirmed diagnosis of CF Key Exclusion Criteria: * Parts A, B, C: * 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 * Part D: * History of clinically significant cirrhosis with or without portal hypertension. 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
  • Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — From Signing of Informed Consent up to Day 105

Trial sites (1)

FacilityCityRegionStatus
Altasciences - Kansas City Overland Park Kansas Recruiting

More Vertex Pharmaceuticals Incorporated trials in the USA

Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy Recruiting
A Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1) Active, not recruiting
An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant Recruiting
A Phase 1 Relative Bioavailability Study of a VX-581 Tablet Formulation Active, not recruiting
Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants Recruiting

Other trials for the same condition

A Study Assessing KB407 for the Treatment of Cystic Fibrosis Recruiting
A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF Active, not recruiting
A Phase 1 Relative Bioavailability Study of a VX-581 Tablet Formulation Active, not recruiting
Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants Recruiting
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy Active, not 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