VX-272 Safety Study
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and metabolism of a new treatment called VX-272. Researchers will administer either one dose or multiple doses of the drug to participants, while others will receive a placebo (a harmless pill with no effect). The study seeks individuals with a body mass index (BMI) between 18 and 32, weighing more than 50 kg, and unable to have children. Participants should not have had any recent illnesses or conditions that affect medicine absorption. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
Is there any evidence suggesting that VX-272 is likely to be safe for humans?
An earlier study tested VX-272 on healthy individuals to assess its safety and tolerability. Researchers administered varying doses to observe the body's reaction to the drug. No serious side effects have been reported, suggesting that VX-272 is well-tolerated. However, as this is an early-stage trial, further research is necessary to confirm its safety.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about VX-272 because it offers a fresh approach to treating conditions typically managed by existing medications. Unlike standard treatments that often target symptoms broadly, VX-272 is being investigated for its potential to act more precisely on the underlying mechanisms of the condition. Additionally, VX-272 is administered in both single and multiple ascending doses, which may provide more flexibility in how it's used and tailored to patient needs. This could lead to more effective management with potentially fewer side effects, making it a promising candidate in the realm of new treatment options.
What evidence suggests that VX-272 could be an effective treatment?
Research has shown that VX-272 is under study to assess its safety and how the body processes it, rather than its effectiveness for a specific illness. In earlier tests with people, VX-272 was mostly well tolerated, with no serious side effects. Minor side effects included nasal discomfort, nausea, headache, and vomiting. VX-272 is being developed as a potential treatment for cystic fibrosis, a disease affecting the lungs and digestive system. This trial primarily focuses on understanding its safety, an essential first step before determining its effectiveness in treating diseases. Participants in this trial will receive either a single or multiple ascending doses of VX-272 or a placebo, assigned randomly.12367
Are You a Good Fit for This Trial?
This trial is for healthy adults (men and women who can't become pregnant) weighing over 50 kg with a BMI between 18 and 32. People cannot join if they have conditions that affect how medicine is absorbed or if they've had a recent illness in the past two weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Part A: Single Ascending Dose
Participants receive a single dose of VX-272 or placebo
Treatment - Part B: Multiple Ascending Dose
Participants receive multiple doses of VX-272 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VX-272
Trial Overview
The study tests different single and multiple doses of a new drug called VX-272 compared to placebo, aiming to see how safe it is, how well people tolerate it, and how the body processes the drug.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will be randomized to receive multiple doses of VX-272.
Participants will be randomized to receive a single dose of VX-272.
Participants will be randomized to receive a single dose of placebo matched to VX-272.
Participants will be randomized to receive multiple doses of placebo matched to VX-272.
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Who Is Running the Clinical Trial?
Vertex Pharmaceuticals Incorporated
Lead Sponsor
Dr. David Altshuler
Vertex Pharmaceuticals Incorporated
Chief Medical Officer since 2020
MD, PhD
Dr. Reshma Kewalramani
Vertex Pharmaceuticals Incorporated
Chief Executive Officer since 2020
MD, trained in internal medicine and nephrology
Citations
Dose Escalation Study Evaluating the Safety and ...
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of VX-272 in healthy participants.
2.
ctv.veeva.com
ctv.veeva.com/study/dose-escalation-study-evaluating-the-safety-and-pharmacokinetics-of-vx-272-in-healthy-participantsDose Escalation Study Evaluating the Safety and ...
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of VX-272.
VX-272 Safety Study · Recruiting Participants for Phase ...
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of VX-272. Show more ...
Dose Escalation Study Evaluating the Safety and ...
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of VX-272.
VX-272 - Drug Targets, Indications, Patents
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-272 in Healthy ...
VX 272 - AdisInsight
VX 272 is being developed by Vertex Pharmaceuticals for the treatment of cystic fibrosis. Clinical development is ongoing in the US.
210491Orig1s000 | FDA
Results of genetic toxicity, carcinogenicity, and developmental and reproductive toxicity studies are described in the approved labeling.
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