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A Study to Evaluate the Effect of Food on the Pharmacokinetics of VX-548
Salt Lake City, UT
Phase 1
Waitlist Available
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug called VX-548 in healthy people to see how it behaves in their bodies and if it is safe. Researchers want to understand how the drug moves through and affects the body before using it on patients with specific conditions.
See full description
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2021 Phase 2 trial • 303 Patients • NCT0503495230%
Nausea
12%
Constipation
11%
Dizziness
11%
Vomiting
7%
Headache
4%
Hypotension
3%
Hyperhidrosis
1%
Hypoxia
1%
Laryngeal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
HB/APAP
VX-548 High Dose
VX-548 Low Dose
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: VX-548Experimental Treatment1 Intervention
Participants will be randomized to receive a single dose of VX-548 in 1 of 6 treatment sequences with 3 dosing periods to assess different fed conditions and timing of meal administration on the PK of VX 548. There will be a 14 day washout period between each dosing period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-548
2022
Completed Phase 3
~3750
Find a Location
Closest Location:ICON Salt Lake City· Salt Lake City, UT· 1513 miles
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Vertex Pharmaceuticals IncorporatedLead Sponsor
263 Previous Clinical Trials
35,670 Total Patients Enrolled
22 Trials studying Pain
1,387 Patients Enrolled for Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: VX-548
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.