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Sequence 1 for Cystic Fibrosis

Phase 1

Recruiting

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 pre-dose up to 192 hours post-dose

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ pre-dose up to 192 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose up to 192 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose up to 192 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under the Concentration Versus Time Curve (AUC) of VX-118

Maximum Observed Plasma Concentration (Cmax) of VX-118

Secondary outcome measures

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)

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.

Do I qualify?Apply below to find out

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

244 Previous Clinical Trials

32,415 Total Patients Enrolled

126 Trials studying Cystic Fibrosis

17,735 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do individuals above the age of 85 meet the criteria for participation in this medical study?

"Individuals aged between 18 and 55 years are eligible for enrollment as per the study's inclusion criteria."

Answered by AI

Is this medical study currently accepting participants for enrollment?

"The clinical trial, as detailed on clinicaltrials.gov, is actively seeking participants. It was publicly announced on April 2nd of the year 2024 and underwent its most recent revision on April 9th of the same year."

Answered by AI

What is the total number of subjects being examined in this particular research investigation?

"Indeed, as per clinicaltrials.gov, this trial is actively seeking participants. It was initially posted on April 2nd, 2024 and last updated on April 9th, 2024. The study aims to enroll 15 individuals at a single site."

Answered by AI

Which individuals meet the criteria for participation in this experimental endeavor?

"This research is seeking to enroll 15 individuals aged between 18 and 55 with an existing diagnosis of cystic fibrosis. In addition, eligible participants must meet the following conditions: a body mass index (BMI) falling within the range of 18.0 to 32.0 kilograms per square meter (kg/m^2), inclusive; individuals who are not capable of bearing children; and a total body weight exceeding 50 kg."

Answered by AI

Has Sequence 1 received approval from the FDA?

"Based on the team's evaluation at Power, Sequence 1 received a safety rating of 1 due to being in the initial Phase 1 trial stage with limited evidence supporting both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet Formulation

2024. "A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet Formulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06312787.

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