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VX-634 for Alpha-1 Antitrypsin Deficiency

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
Participants of non childbearing potential
Non smoker or ex-smoker for at least 3 months before screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a cohort a3: days 1 and 5; part b cohort b3: days 1, 10 and 11
Awards & highlights

Study Summary

This trial tests the safety and how the body processes a new drug, VX-634, when taken at different doses.

Who is the study for?
This trial is for adults aged 18-55 with Alpha-1 Antitrypsin Deficiency. They must weigh over 50 kg, have a BMI of 18 to 32, and be non-smokers or ex-smokers for at least three months. It's not suitable for those who might have issues absorbing drugs.Check my eligibility
What is being tested?
VX-634 is being tested against a placebo to check its safety and how the body processes it at different doses. This first-in-human study will help understand if VX-634 can be safely administered.See study design
What are the potential side effects?
Since this is a first-in-human study, specific side effects are unknown but may include typical drug reactions like nausea, headaches, allergic reactions, or other unforeseen issues related to the new medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot become pregnant.
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I have not smoked for at least 3 months.
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I am between 18 and 55 years old.
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I weigh more than 50 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a cohort a3: days 1 and 5; part b cohort b3: days 1, 10 and 11
This trial's timeline: 3 weeks for screening, Varies for treatment, and part a cohort a3: days 1 and 5; part b cohort b3: days 1, 10 and 11 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 and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Part A and B: Area Under the Concentration Versus Time Curve (AUC) of VX-634
Part A and B: Maximum Observed Plasma Concentration (Cmax) of VX-634
Part A and B: Urine Concentration of VX-634

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part BExperimental Treatment1 Intervention
Participants grouped in different cohorts will receive multiple doses of VX-634.The dose levels will be determined based on the data from Part A.
Group II: Part AExperimental Treatment1 Intervention
Participants grouped in different cohorts will receive a single ascending dose of VX-634.
Group III: Placebo Part APlacebo Group1 Intervention
Participants will be randomized to receive placebo matched to VX-634.
Group IV: Placebo Part BPlacebo Group1 Intervention
Participants will be randomized to receive placebo matched to VX-634.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-634
2022
Completed Phase 1
~130

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
32,260 Total Patients Enrolled

Frequently Asked Questions

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

Could you explain the potential perils of Part A for participants?

"Due to limited data regarding the efficacy and safety of Part A, our team at Power gave it a score of 1."

Answered by AI

Is the age eligibility for this clinical trial open-ended, or does it exclude those 75 years and older?

"To be eligible for this medical study, participants must fall between 18 and 55 years of age. For those above or below that range, there are 1 trial available to minors and 11 trials designed specifically for seniors."

Answered by AI

Can I be an active participant in this experiment?

"This clinical trial seeks 114 individuals with alpha 1-antitrypsin deficiency in the 18 to 55 year old range. The requisite criteria includes a body weight of above 50 kg, non childbearing potential, abstinence from smoking for 3 months prior to screening, and a BMI between 18 - 32 kg/m^2."

Answered by AI

What is the total number of participants in this clinical trial?

"Affirmative. Evidently, the information provided on clinicaltrials.gov demonstrates that this medical trial is actively seeking volunteers; it was initially published on October 13th 2022 and has been recently modified November 9th 2022. The research requires 114 subjects from 1 respective centre to be recruited."

Answered by AI

Are there any openings for participation in this clinical trial?

"As indicated by the information published on clinicaltrials.gov, this trial is actively seeking patients to participate. The original posting was made in October 13th 2022 and it has been altered most recently on November 9th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1, First-in-human Study of VX-634
2022. "A Phase 1, First-in-human Study of VX-634". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05579431.
~51 spots leftby Apr 2025
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