Evaluating the safety and effects of VX-407 in healthy individuals
A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of VX-407 in Healthy Subjects
PHASE1 · Vertex Pharmaceuticals Incorporated · NCT06345755
This study is testing a new drug called VX-407 in healthy people to see if it's safe and how it works in the body, which could help in treating conditions like Autosomal Dominant Polycystic Kidney Disease.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 119 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Vertex Pharmaceuticals Incorporated (industry) |
| Locations | 2 sites (Lenexa, Kansas and 1 other locations) |
| Trial ID | NCT06345755 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, and pharmacokinetics of a drug called VX-407 in healthy participants. The study will involve administering VX-407 and a placebo to evaluate how the drug is processed in the body and its overall safety profile. Participants will be monitored for any adverse effects and how their bodies respond to the medication. The findings from this trial could provide important insights into the drug's potential use for treating conditions like Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults with a BMI between 18.0 and 32.0 kg/m² and a body weight greater than 50 kg.
Not a fit: Patients with a history of acute illnesses or conditions affecting drug absorption may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients with ADPKD.
How similar studies have performed: Other studies evaluating similar pharmacological approaches have shown promise, but this specific drug's effects are novel.
Eligibility criteria
Show full inclusion / exclusion 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 greater than (\>) 50 kg * Nonsmoker or ex-smoker for at least 3 months before 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.
Where this trial is running
Lenexa, Kansas and 1 other locations
- ICON Lenexa — Lenexa, Kansas, United States (RECRUITING)
- Altasciences Montreal — Montreal, Canada (RECRUITING)
Study contacts
- Study coordinator: Medical Information
- Email: medicalinfo@vrtx.com
- Phone: 617-341-6777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autosomal Dominant Polycystic Kidney Disease