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A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet Formulation
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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to test how well the tablet form of VX-118 is absorbed in the body compared to other forms, how food affects its levels in the body, and if it is safe for healthy
Who is the study for?
This trial is for healthy individuals with a BMI between 18.0 to 32.0 Kg/m^2 and weighing over 50 kg. Participants must not be able to bear children, indicating they could be males or females who are postmenopausal or surgically sterile.
What is being tested?
The study is testing VX-118, a new tablet formulation for cystic fibrosis treatment. It aims to understand how the body absorbs this drug, how food affects its absorption (bioavailability), and what doses are safe and tolerable.
What are the potential side effects?
While specific side effects aren't listed here, common ones may include digestive issues, allergic reactions, headaches, or fatigue as the body's response to new medication.
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Sequence 3Experimental Treatment1 Intervention
Participants will receive a single dose of VX-118 as tablets in the fed state in dosing period 1, followed by a single dose of VX-118 as a suspension in the fasted state in dosing period 2, followed by a single dose of VX-118 as tablets in the fasted state in dosing period 3. A washout period of 8 days will be maintained between the 3 dosing periods.
Group II: Sequence 2Experimental Treatment1 Intervention
Participants will receive a single dose of VX-118 as tablets in the fasted state in dosing period 1, followed by a single dose of VX-118 as tablets in the fed state in dosing period 2, followed by a single dose of VX-118 as a suspension in the fasted state in dosing period 3. A washout period of 8 days will be maintained between the 3 dosing periods.
Group III: Sequence 1Experimental Treatment1 Intervention
Participants will receive a single dose of VX-118 as a suspension in the fasted state in dosing period 1, followed by a single dose of VX-118 as tablets in the fasted state in dosing period 2, followed by a single dose of VX-118 as tablets in the fed state in dosing period 3. A washout period of 8 days will be maintained between the 3 dosing periods.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-118
2024
Completed Phase 1
~20
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Vertex Pharmaceuticals IncorporatedLead Sponsor
257 Previous Clinical Trials
35,054 Total Patients Enrolled
128 Trials studying Cystic Fibrosis
17,930 Patients Enrolled for Cystic Fibrosis