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Part A: Single Ascending Dose (SAD) 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

A total body weight of more than (>) 50 kg

Key

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 up to day 34

Awards & highlights

Study Summary

This trial is being conducted to test the safety, side effects, and how the drug VX-828 is processed in the bodies of healthy individuals.

Who is the study for?

This trial is for healthy adults with a BMI of 18.0 to 32.0 kg/m^2 and weighing over 50 kg. Participants should be nonsmokers or ex-smokers who quit at least 3 months prior, confirmed by tests.Check my eligibility

What is being tested?

The study is testing VX-828's safety, how well it's tolerated, and its pharmacokinetics (how the drug moves through the body). It involves comparing VX-828 with Midazolam (a control drug), Itraconazole (to check interactions), and a placebo.See study design

What are the potential side effects?

Possible side effects are not detailed but may include reactions typical of clinical trials such as headaches, nausea, dizziness or allergic reactions due to the investigational nature of VX-828.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh more than 50 kg.

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It seems like the criterion is incomplete. Could you please provide more details or context so I can assist you better?

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 up to day 34

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 up to day 34

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to day 34 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

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)

Part C: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Plasma in the Absence and Presence of VX-828

+3 more

Secondary outcome measures

Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-828 in Plasma

Part A: Maximum Observed Concentration (Cmax) of VX-828 in Plasma

Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-828 at Steady State in Plasma

+2 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Part C: Drug Drug InteractionExperimental Treatment3 Interventions

Participants will receive a single dose of VX-828, followed by a washout period, Itraconazole administration, and concomitant administration of itraconazole and VX-828; or participants will receive Midazolam followed by VX-828 administration, and concomitant administration of VX-828 and Midazolam. Part C will be an open-label optional cohort.

Group II: Part B: Multiple Ascending Dose (MAD)Experimental Treatment1 Intervention

Participants will be randomized to receive multiple doses of different dose levels of VX-828. The dose levels will be determined based on the data from Part A.

Group III: Part A: Single Ascending Dose (SAD)Experimental Treatment1 Intervention

Participants will be randomized to receive a single dose of different dose levels of VX-828.

Group IV: Part A: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive placebo matched to VX-828.

Group V: Part B: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive placebo matched to VX-828.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Itraconazole

2017

Completed Phase 2

~780

Midazolam

2018

Completed Phase 4

~1910

0 / 2Eligibility criteria met

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

243 Previous Clinical Trials

32,230 Total Patients Enrolled

126 Trials studying Cystic Fibrosis

17,592 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.

Are individuals presently able to enroll in this clinical trial?

"Indeed, clinicaltrials.gov indicates that this trial is presently seeking eligible participants. The initial posting date for the study was December 12th, 2023, and it was last modified on December 21st, 2023."

Answered by AI

What is the current number of participants enrolled in this clinical research study?

"Indeed, the information on clinicaltrials.gov supports the active recruitment of patients for this study. The trial was initially posted on December 12th, 2023 and last updated on December 21st, 2023. A total of 157 participants will be enrolled from a single site."

Answered by AI

What is the level of safety regarding drug-drug interactions in Part C for patients?

"Given that this is a Phase 1 trial, the safety of Part C: Drug-Drug Interaction is estimated to be at level 1 by our team at Power. This implies limited data supporting both safety and efficacy."

Answered by AI

Is there an age restriction for potential participants in this study, specifically regarding individuals who are 65 years old or older?

"To be eligible for this clinical trial, interested individuals must fall within the age range of 18 to 55 years. It's noteworthy that there are a total of 60 ongoing trials specifically targeting participants under the age of 18 and an additional 82 trials designed for patients over the age of 65."

Answered by AI