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VX-668 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 age between 18 to 55 years (inclusive)
Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)
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 a drug to see if it's safe and how it works in the body.

Who is the study for?
This trial is for adults aged 18-55 with Alpha-1 Antitrypsin Deficiency. They must have a BMI of 18 to 32, weigh over 50 kg, and be non-smokers or haven't smoked for at least three months. Women who can become pregnant are excluded.Check my eligibility
What is being tested?
The study tests VX-668 against a placebo to assess its safety, how well it's tolerated by the body, and how the body processes various doses in people with Alpha-1 Antitrypsin Deficiency.See study design
What are the potential side effects?
Possible side effects of VX-668 aren't detailed but typically include reactions at the injection site, gastrointestinal symptoms, headaches, fatigue or allergic responses due to it being first-in-human testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 18 and 55 years old.
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Your body mass index (BMI) is between 18.0 and 32.0.
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You weigh more than 50 kilograms.
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You have not smoked, or you quit smoking at least 3 months ago.

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-668
Part A and B: Maximum Observed Plasma Concentration (Cmax) of VX-668
Part A and B: Urine Concentration of VX-668

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-668.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-668.
Group III: Placebo Part APlacebo Group1 Intervention
Participants will be randomized to receive placebo matched to VX-668.
Group IV: Placebo Part BPlacebo Group1 Intervention
Participants will be randomized to receive placebo matched to VX-668.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-668
2023
Completed Phase 1
~120

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
32,273 Total Patients Enrolled

Media Library

VX-668 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05727800 — Phase 1
Alpha-1 Antitrypsin Deficiency Research Study Groups: Part A, Placebo Part A, Part B, Placebo Part B
Alpha-1 Antitrypsin Deficiency Clinical Trial 2023: VX-668 Highlights & Side Effects. Trial Name: NCT05727800 — Phase 1
VX-668 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05727800 — Phase 1

Frequently Asked Questions

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

Has Part A received the green light from the Food and Drug Administration?

"The lack of data related to Part A's safety and efficacy warrants a score of 1 on the scale from 1-3. This is due to it being in its initial phase of clinical trials."

Answered by AI

Is the age restriction above 35 applicable to potential participants of this experiment?

"This trial has outlined a specific age range for eligible applicants, who must be between 18 and 55. For those under the legal age of consent or over 65 years old, there are 13 other medical trials that may be more suitable."

Answered by AI

Are researchers still enrolling participants in this experiment?

"The information posted on clinicaltrials.gov details that recruitment for this medical trial is underway, with the first post being made available on February 8th 2023 and a subsequent update occurring March 3rd 2023."

Answered by AI

Who meets the eligibility requirements for participation in this medical trial?

"This clinical trial is seeking 114 individuals with alpha-1 antitrypsin deficiency who are in the age bracket of 18 to 55. To qualify, applicants must have a BMI between 18.0 and 32.0 kg/m^2 as well as total body weight exceeding 50 kg; additionally, they should be either non-smokers or ex-smokers for at least 3 months prior to screening."

Answered by AI

How many participants are included in the current trial?

"Affirmative. The clinical trial data hosted on clinicaltrials.gov attests to the fact that this study is actively recruiting patients, having first been posted on February 8th 2023 and last updated March 3rd of the same year. An estimated 114 participants will be recruited from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1, First-in-human Study of VX-668
2023. "A Phase 1, First-in-human Study of VX-668". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05727800.
~53 spots leftby Apr 2025
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