NCT07283770 Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants
| NCT ID | NCT07283770 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Vertex Pharmaceuticals Incorporated |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2025-12-09 |
| Primary Completion | 2026-11-19 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 128 participants in total. It began in 2025-12-09 with a primary completion date of 2026-11-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07283770 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07283770 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07283770 currently recruiting?
Yes, NCT07283770 is actively recruiting participants. Contact the research team at medicalinfo@vrtx.com for enrollment information.
Where is the NCT07283770 trial being conducted?
This trial is being conducted at Overland Park, United States.
Who is sponsoring the NCT07283770 clinical trial?
NCT07283770 is sponsored by Vertex Pharmaceuticals Incorporated. The trial plans to enroll 128 participants.