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Clinical Trials in the USA / NCT07813039
Recruiting Phase 1

A Phase 1 Relative Bioavailability Study of a VX-581 Tablet Formulation

NCT07813039 · tracked via the Priya Life Science USA tracker
Sponsor
Vertex Pharmaceuticals Incorporated
Phase
Phase 1
Started
2026-09-23
Last updated
2026-10-19

Condition(s) studied

Cystic Fibrosis

Investigational drug(s) / intervention(s)

VX-581 →

VX-581: Tablet and Suspension for Oral Administration.

Study summary

The purpose of this study is to evaluate the relative bioavailability of VX-581 tablet formulation compared to a suspension formulation along with its safety and tolerability.

Eligibility

Sex
MALE
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), inclusive * Total body weight of greater than (\>) 50 kg * Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening 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)

  • Maximum Observed Plasma Concentration (Cmax) of VX-581 — Period 1 and Period 2: From Day 1 up to Day 21
  • Area Under the Concentration Versus Time Curve (AUC) of VX-581 — Period 1 and Period 2: From Day 1 up to Day 21

Trial sites (1)

FacilityCityRegionStatus
Celerion - Tempe Tempe Arizona Recruiting

More Vertex Pharmaceuticals Incorporated trials in the USA

Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age Active, not recruiting
A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis 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
A Long-term Follow-up Study in Participants Who Received CTX001 Enrolling by invitation
A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes Recruiting

Other trials for the same condition

Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age Active, not 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
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis Recruiting
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF) Recruiting
Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants 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 NCT07813039 on ClinicalTrials.gov ↗ ← All trials in the USA