Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants
Phase 1
128
about 12 months
18–55
1 site in KS
What this study is about
Researchers are testing a treatment called VX-581 to see if it's safe and how it works in healthy people. The trial will last for 345 days, with participants receiving either a placebo or VX-581.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Placebo
- 2.Take VX-581
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary: Part A: Maximum Observed Plasma Concentration (Cmax) of VX-581, Part B: Maximum Observed Plasma Concentration (Cmax) of VX-581
Respiratory